Safety Information
Product Recall
Written by Kobu
Product Recall
Definition
Product recall is a process taken by the manufacturer, importer and wholesaler to remove or withdraw a particular products from all links of distribution.
The removal or withdrawal may be due to critical quality defects discovered or serious adverse drug reactions reported which might cause health risks to users of the products.
Decision For Recall
The decision for recall shall be made when there is or may caused potential risk to the user of the products by reason of faulty production or on medical grounds:
a) Voluntarily undertaken by the manufacturers and distributors.
b) As directed by the Director of Pharmaceutical Services, Ministry of Health.
Unless the Director of Pharmaceutical Services, Ministry of Health has already specified the degree and level of a particular products recall, the degree and level will be decided by the company’s Product Recall Committee based on risks involved. The Product Recall Committee shall comprise of personnel who are responsible for the execution and coordination of recall. The persons responsible shall handle all aspects of the recalls with the appropriate degree of urgency.
No recall shall take place without first consulting/informing the Authority.
Recalls that involve specific batch will not involve any other batch/batches that currently available in the market.
Not all recalls are initiated because a product is deemed unsafe or ineffective. A recall may also be conducted to remove products from the Malaysian market with quality defects that do not affect their safety and efficacy.
Degree of Recall
The degree of recall is classified according to the severity of quality defects and adverse reactions of the products.
| Degree | Definition | Recall Notice by PRH |
| I | Products with major health risks that might cause serious injuries or death. Should be under an embargo within 24 hours | Within 24 hours of recall commencement or directive |
| II | Products with minor health risks or are substandard. Should be under an embargo within 72 hours | Within 48 hours of recall commencement or directive |
| III | Products with other reasons for recall that can cause health risks to users. Should be under an embargo within 30 days or as specified | Within 72 hours of recall commencement or directive |
Level of Recall
The level of recall depends on the nature of problem, extent of the product’s distribution and degree of hazard involved.
Level A: To all consumers (end users).
Level B: To all points of sales (e.g. Hospitals, Pharmacies, Clinics, Specialist Centres).
Level C: To all sub-distributors (wholesalers).
Public Notification
Not all recalls are announced in press releases. However, when a product that has been widely distributed or poses a serious health hazard is recalled, NPRA may do so if the agency determines it is necessary to protect consumers.
References:
1) Drug Registration Guidance Document (DRGD)
2) Guideline on Good Distribution Practice
Products as listed below have been recalled from the market.
Year 2026
|
No |
Product Name |
Registration Number |
Active ingredients |
Batch Number |
Reason for Recall |
Degree and Level of Recall |
Registration Holder |
Date of recall |
|
1 |
COREDIN PAEDIATRIC LINCTUS |
MAL19880311AZ |
|
19574, 19616 |
Precautionary measure following a complaint regarding the presence of particles confirmed to have originated from sugar crystallization in the product formulation. |
Voluntary recall at the point of sub-distributor (wholesaler) |
TERAPUTICS SDN BHD |
30 January 2026 |
|
2 |
VAMLO TABLETS 10MG |
MAL07010993AZ |
Amlodipine |
24030132 |
Out of Trend (OOT) result for Related Substances “Impurity D” test at 18th month timepoint of stability study. |
Voluntary recall up to the point of sales |
RANBAXY (MALAYSIA) SDN. BHD. |
13 February 2026 |
|
3 |
DOXYCILLIN TABLET 100MG |
MAL19860580AZ |
Doxycycline Hydrochloride/ Hyclate |
2403300, 2403301, 2405293 |
Out of specification result for related substance “Impurity C” test during the stability study. |
Voluntary recall up to the point of sales |
DUOPHARMA MANUFACTURING (BANGI) SDN. BHD. |
19 February 2026 |
|
4 |
Uphamol Menstrual Tablet 500/25mg |
MAL12025061X |
|
2310222 |
Out-of-specification result was observed for the dissolution test during the stability study. |
Voluntary recall up to the point of sales |
Duopharma Marketing Sdn. Bhd. |
9 February 2026 |
|
5 |
Pro-Stisol Waist & Body Tonic Tablet |
MAL16100054T |
|
013/2412 T22-004 |
The batch tested by NPRA had failed physical appearance test |
Degree III recall up to the point of sales |
Pro Stisol Manufacturing |
13 Mac 2026 |
|
6 |
Vitamode Astaxanthin Plus Glutathione Capsule |
MAL15045003NC |
|
5NC10503 |
Product labelling on the blister strip found to be incorrect. |
Voluntary recall up to the point of sales |
Medispec (M) Sdn. Bhd. |
16 Mac 2026 |
|
Last updated 23/04/2026 |
||||||||
Year 2025
|
No |
Product Name |
Registration Number |
Active ingredients |
Batch Number |
Reason for Recall |
Degree and Level of Recall |
Registration Holder |
Date of recall |
|
1 |
Bio Spektra Inji Plus Capsule |
MAL11125063TC |
Multiple active ingredients |
MAI23039 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count and Total Yeasts and Moulds Count above allowable limit |
Degree III recall up to the point of sales |
AK Pharmacy & Naturopathy Center |
7 January 2025 |
|
2 |
Hongjitang Xin Angong Niuhang Pill |
MAL20172976T |
Multiple active ingredients |
2402001 |
The batch tested by NPRA found to contain arsenic and mercury above allowable limit |
Degree II recall up to the point of sales |
Hai-O Medicine Sdn. Bhd. |
7 January 2025 |
|
3 |
Ban Kah Chai Gold Brand Fu Leu Wu Chin Wan |
MAL20020656T |
Multiple active ingredients |
2401-24A07 |
The batch tested by NPRA found to contain cadmium above allowable limit |
Degree II recall up to the point of sales |
Ban Kah Chai Pharmaceutical Sdn. Bhd. |
7 January 2025 |
|
4 |
Ban Kah Chai Herbal Capsule |
MAL20020653T |
Multiple active ingredients |
2404-24D05 |
The batch tested by NPRA found to contain cadmium above allowable limit |
Degree II recall up to the point of sales |
Ban Kah Chai Pharmaceutical Sdn. Bhd. |
7 January 2025 |
|
5 |
Zaipermai Capsule Faruqi |
MAL22096119TC |
Multiple active ingredients |
TA3ZZA3ZZSF 003-24 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Zai Permai Resources |
7 January 2025 |
|
6 |
Ubat Serbuk Sakit Perut Cap Tangan |
MAL19984513T |
Multiple active ingredients |
S2310001 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Ban An Tsi Company Sdn. Bhd. |
7 January 2025 |
|
7 |
Yi Shi Yuan Red Yeast Rice 300mg Capsule |
MAL17126023T |
Monascus purpureus |
B11001 |
The batch tested by NPRA found to contain Lovastatin above the allowable limit. |
Degree III recall up to the point of sales |
Yi Si Yuan Trading Sdn. Bhd. |
7 January 2025 |
|
8 |
RO-CAL 0.25mcg |
MAL10070596X |
Calcitriol |
1) 23G24 2) 23G25 3) 23G26 |
Out-of-specification result for the product’s description and assay test during stability study |
Voluntary recall up to the point of sales |
Pahang Pharmacy Sdn. Bhd. |
24 January 2025 |
|
9 |
NW Methyl Salicylate 25%W/W Ointment |
MAL18046134X |
Methyl salicylate |
1) NW25M27016 2) NW25M27017 3) NW25M27018 4) NW25M27019 5) NW25M27024 6) NW25M27025 7) NW25M27026 |
Batches of product manufactured and distributed without valid manufacturing license due to GMP issue |
Degree II recall up to the point of sales |
Natural Wellness Industries Sdn. Bhd. (Milik Penuh Nutrivention Sdn. Bhd) |
14 February 2025 |
|
10 |
Natural Wellness Aqueous Cream |
MAL20172844X |
White soft paraffin Emulsifying Wax Liquid Paraffin |
1) NW25M27035 2) NW25M27036 3) NW25M27037 4) NW25M27038 5) NW25M27039 6) NW25M27040 7) NW25M27041 8) NW25M27042 9) NW25M27001 10) NW25M27002 11) NW25M27003 12) NW25M27004 13) NW25M27005 14) NW25M27006 15) NW25M27007 16) NW25M27008 17) NW25M27009 18) NW25M27010 19) NW25M27011 20) NW25M27012 21) NW25M27013 22) NW25M27014 23) NW25M27015 24) NW25M27027 25) NW25M27028 26) NW25M27029 27) NW25M27030 28) NW25M27031 29) NW25M27032 30) NW25M27033 31) NW25M27034 |
Batches of product manufactured and distributed without valid manufacturing license due to GMP issue |
Degree II recall up to the point of sales |
Natural Wellness Industries Sdn. Bhd. (Milik Penuh Nutrivention Sdn. Bhd) |
14 February 2025 |
|
11 |
Petani Kapsul Pukul Angin |
MAL06111395T |
Multiple active ingredients |
A352KPA |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit. |
Degree III recall up to the point of sales |
Syarikat Zulkifli Bamadhaj (Malaysia) |
28 February 2025 |
|
12 |
Listra Habbasauda Plus Capsules |
MAL17106012TC |
|
TAAAZZAALA01124 |
The batch tested by NPRA was found to contain Total Aerobic Microbial Count and Bile-tolerant Gram-Negative Bacteria above the allowable limit. |
Degree III recall up to the point of sales |
Bina Mutiara Global Sdn. Bhd. |
28 February 2025 |
|
13 |
Shangshi Koyok |
MAL14125040TC |
|
38320701 |
The batch tested by NPRA was found to contain unapproved Methyl Salicylate and Menthol. |
Degree II recall up to the point of sales |
Teong Huat Medical Sdn. Bhd. |
28 February 2025 |
|
14 |
Herbal Farm N7 Capsule |
MAL22046118TC |
Multiple active ingredients |
NSC24067 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Herbal Farm |
28 February 2025 |
|
15 |
Dexin Injection 2mL |
MAL20013450AZ |
Dexamethasone |
DX 24A 001 |
The batch tested by NPRA had failed assay test for Propyl Paraben and Methyl Paraben |
Degree III recall up to the point of sales |
Sm Pharmaceuticals Sdn. Bhd. |
28 February 2025 |
|
16 |
Famodine Tablet 20mg |
MAL19096018AE |
Famotidine |
231015 |
Batch showed out-of-specification (OOS) of Famotidine assay result during stability studies. |
Voluntary recall up to the point of sales |
Duopharma (M) Sendirian Berhad, Malaysia |
25 March 2025 |
|
17 |
Neupogen 30MIO 0.3mg/ml Vial |
MAL19921256AZ |
Recombinant Human Granulocyte Colony-stimulating Factor (Filgrastim) |
|
Out of specification (OOS) for purity test was observed in Inspected Drug Product (IDP) failed purity testing at 36 months stability study, showing less than 95% purity. |
Voluntary recall up to the point of sales |
Amgen Biopharmaceuticals Malaysia Sdn. Bhd. |
26 March 2025 |
|
18 |
SHH Habib Roll On Gel |
MAL22026104TC |
Multiple active ingredients |
TAAAZA 112-23 |
The batch tested by NPRA was found to contain undeclared Methyl Salicylate. |
Degree III recall up to the point of sales |
SHH Northern Legacy (M) Sdn. Bhd. |
21 April 2025 |
|
19 |
Nutriflex Omega Special Emulsion For Infusion |
MAL14115005AZ |
Multiple active ingredients |
240678051 |
This recall is being conducted due to an out-of-specification result for the product’s physical appearance test during stability study |
Voluntary recall up to the point of sales |
B.Braun Medical Industries Sdn. Bhd. |
30 April 2025 |
|
20 |
Teleact Tablets 80mg |
MAL13015032AZ |
Telmisartan |
MLG0026A |
OOS (out-of-specification) & OOT (out-of-trend) for Microbial Limit Test in the API batches used in the manufacturing batch |
Voluntary recall up to the point of sales |
Ranbaxy (Malaysia) Sdn. Bhd. |
30 April 2025 |
|
21 |
Utrogestan 100mg Capsule |
MAL19971796ACZ |
Progesterone |
252130 |
This recall is being conducted due to labelling error on the outer packaging. |
Voluntary recall up to the point of sales |
Syarikat WellChem Sdn. Bhd. |
30 April 2025 |
|
22 |
ELONIDE Nasal Spray 50 mcg/dose |
MAL12015004AZ |
Mometasone Furoate |
1) 06387206 2) 06367206 3) 06357206 4) 06377206 5) 07157206 6) 07167206 7) 1223C206 8) 1224C206 9) 1225C206 10) 1283C206 11) 1320C206 12) 1321C206 13) 00711304 14) 00721306 15) 01102306 16) 01112306 17) 01122306 18) 01132306 19) 01293206 20) 01302306 21) 1051A306 22) 1052A306 23) 1142B306 24) 1143B306 25) 1589C406 26) 1590C406 27) 1591C406 28) 05866206 29) 1222C206 30) 02483306 |
This recall is being conducted due to the detection of bacterial contamination in several batches. |
Voluntary recall up to all consumers level (end users) |
Hoe Pharmaceuticals Sdn. Bhd. |
8 May 2025 |
|
23 |
Depropin Tablet 25mg |
MAL20012730AZ |
Dothiepin HCl |
230985L |
Batch showed out-of-specification (OOS) of Dothiepin Hydrochloride assay result during Zon IVB real-time stability studies. |
Voluntary recall up to the point of sales |
Duopharma (M) Sendirian Berhad, Malaysia |
16 May 2025 |
|
24 |
Vigouroxy |
MAL06091569T |
Multiple active ingredients |
062409V |
Batch showed cadmium assay is above the allowable limit. |
Voluntary recall up to the point of sales |
Nature's Grace (M) Sdn. Bhd. |
29 May 2025 |
|
25 |
PROMUNE mbg Capsule |
MAL18126019NC |
Beta Glucan |
N2411P |
The batch tested by NPRA was found to contain Bile-Tolerant Gram-Negative Bacteria above the allowable limit. |
Degree II recall up to the point of sales |
Powerlife (M) Sdn. Bhd. |
26 June 2025 |
|
26 |
Chang-Sze-Long Badu Gao |
MAL13095093T |
Multiple active ingredients |
All batches |
The batch tested by NPRA was found to contain mercury above the allowable limit. |
Degree II recall up to the point of sales |
Nang Hin Medical Sdn. Bhd. |
26 June 2025 |
|
27 |
Jinfeng Powder |
MAL20032104T |
Multiple active ingredients |
J230618 |
The batch tested by NPRA was found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Di Ann Trading |
26 June 2025 |
|
28 |
Herbal Farm Reposin Capsule |
MAL13055039TC |
Multiple active ingredients |
RPN24028 |
The batch tested by NPRA was found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Herbal Farm |
26 June 2025 |
|
29 |
Minosis Leemi Powder |
MAL17117003TC |
Multiple active ingredients |
24M2042 |
Batch showed out-of-specification (OOS) on Total Aerobic Microbial Count (TAMC) and Total Yeast and Moulds Count (TYMC). |
Voluntary recall up to the point of sales |
Leong 23 Sdn. Bhd. |
27 June 2025 |
|
30 |
Teleact Tablets 80mg |
MAL13015032AZ |
Telmisartan |
|
OOS (out-of-specification) & OOT (out-of-trend) for Microbial Limit Test in the API batches used in the manufacturing batch. |
Voluntary recall up to the point of sales |
Ranbaxy (Malaysia) Sdn. Bhd. |
14 July 2025 |
|
31 |
Betanor 24mg Tablet |
MAL14075064AZ |
Betahistine Dihydrochloride |
|
Batch showed out-of-specification (OOS) of N-nitroso-betahistine impurity. |
Voluntary recall up to the point of sales |
Noripharma Sdn. Bhd. |
22 July 2025 |
|
32 |
Minyak Angin Orang Satu Mata |
MAL05121191X |
|
BBL908 |
The batch tested by NPRA had failed Methyl Salicylate and Camphor assay tests. |
Degree III recall up to the point of sales |
Wen Jiang Medical Industries Sdn. Bhd. |
22 July 2025 |
|
33 |
Cap Gunting Chai Teck Sang Shui Gan Teh 12gm |
MAL20116092TC |
Multiple active ingredients |
24F043 |
The batch tested by NPRA was found to contain Total Aerobic Microbial Count and Bile-tolerant Gram-Negative Bacteria above the allowable limit. |
Degree III recall up to the point of sales |
Chai Teck Sang Medical Hall Sdn. Bhd. |
22 July 2025 |
|
34 |
Calcium Carbonate Tablets ‘MPI’ 500mg |
MAL19940309X |
Calcium Carbonate |
All batches |
Data Integrity Issues In Relation To Quality Control Tests (Dissolution) |
Degree II recall at the point of sub-distributor (wholesaler) |
Malaysian Pharmaceutical Industries Sdn. Bhd. |
4 August 2025 |
|
35 |
STOPCOF Oral Liquid |
MAL09062117T |
Multiple active ingredients |
S24001, S24002, S24003, S24004 |
Batches showed an unusual “pop” sound and gas release upon opening the bottle. |
Voluntary recall up to the point of sales |
Jetpharma Sdn. Bhd. |
8 August 2025 |
|
36 |
Fucidin Tablet 250mg (Film Coated) |
MAL19910821AZ |
Sodium Fusidate |
C97089 |
Batch showed out-of-specification (OOS) of impurities during the stability study. |
Voluntary recall up to the point of sales |
DKSH Malaysia Sdn. Bhd. |
8 August 2025 |
|
37 |
NW Chlorhexidine Gluconate 5%W/V Topical Solution |
MAL18046124XZ |
Chlorhexidine Gluconate |
|
The batch tested by NPRA had failed Chlorhexidine Gluconate Content – HPLC test. |
Degree II recall up to the point of sales |
Natural Wellness Industries Sdn. Bhd. |
20 August 2025 |
|
38 |
ZBT Wenxin Granule |
MAL09072822T |
Multiple active ingredients |
2501023 |
Product labelling found to be not compliant with current labelling requirements. |
Degree III recall up to the point of sales |
ZBT Far East Sdn. Bhd. |
20 August 2025 |
|
39 |
Xie Fu Zhu Yu Tang Extract Granules C.F.T |
MAL13115096T |
Multiple active ingredients |
K0582401M |
The batch tested by NPRA found to contain Bile-Tolerant Gram Negative Bacteria above allowable limit |
Degree III recall up to the point of sales |
Chuan Feng Tang Pharmaceutical (M) Sdn. Bhd. |
20 August 2025 |
|
40 |
Tranpam Tablet 1mg |
MAL19900510A |
Lorazepam |
All batches |
Data Integrity Issues In Relation To Quality Control Tests (Related Substances; Total Impurities) |
Degree II recall up to the point of sales |
Malaysian Pharmaceutical Industries Sdn. Bhd. |
21 August 2025 |
|
41 |
Soft Flow SC Low Calcium (2.5MEQ/L) Peritoneal Dialysis Solution With Dextrose 2.5% W/V |
MAL18116040AZ |
Multiple active ingredients |
|
The voluntary recall is planned following complaints received from users related to leakage of dialysate out into the sealed outer pouch, which may potentially pose a risk to patients, if outer pouch is breached and undetected prior to use. |
Voluntary recall up to the level of hospital and consumers |
Peritone Health Sdn. Bhd. |
25 August 2025 |
|
42 |
Pharmaniaga Co-Amoxiclav Tablet 625mg |
MAL20013767AZ |
Amoxycillin Trihydrate & Clavulanic Acid |
5031276 |
Out-of-specification result for the product’s description during stability study. |
Voluntary recall up to the point of sales |
Idaman Pharma Manufacturing Sdn. Bhd. |
18 August 2025 |
|
43 |
Nisol Injection (10ml Vial) |
MAL20041207AZ |
Nisol Injection (10ml Vial) |
250965L |
Recall due to mislabeling issue reported by a customer. |
Voluntary recall up to the point of sales |
Duopharma (M) Sendirian Berhad |
7 Oktober 2025 |
|
44 |
Hyomide Tablet 10mg |
MAL05101675AZ |
Hyoscine Butylbromide |
2311021 and 2311022 |
Recall due to shortened shelf life approved by NPRA from 3 years to 2 years. |
Voluntary recall up to the point of sales |
Duopharma Maufacturing (Bangi) Sdn Bhd |
9 Oktober 2025 |
|
45 |
Natural Wellness Calamine Cream |
MAL11120009XZ |
Calamine & Zinc Oxide |
NW24M26868 and NW24M26869 |
The batch tested by NRA had failed zinc content – residue on ignition |
Degree II recall up to the point of sales |
Natural Wellness Industries Sdn. Bhd. (Milik Penuh Nutrivention Sdn. Bhd) |
30 Oktober 2025 |
|
46 |
21st Century Herbal Lipo Tea Natural Flavor |
MAL20012794TR |
|
All batches |
The Cassia content in these products exceeds the current allowable limit under the latest Drug Registration Guidance Document (DRGD). |
Voluntary recall up to the point of sales |
21st Century Products Sdn. Bhd. |
31 Oktober 2025 |
|
47 |
21st Century Herbal Lipo Tea Honey Lemon Flavor |
MAL20012801TR |
|
All batches |
The Cassia content in these products exceeds the current allowable limit under the latest Drug Registration Guidance Document (DRGD). |
Voluntary recall up to the point of sales |
21st Century Products Sdn. Bhd. |
31 Oktober 2025 |
|
48 |
MIVACRON 2MG/ML INJ. 10ML AMPOULE |
MAL19940410AZ |
Mivacurium Chloride |
XP1TJ |
Deficiencies in manual visual inspection (MVI) were detected between December 2024 and September 2025. According to the investigation, potentially not all glass particles in the ampoules have been detected during the MVI process. |
Voluntary recall up to the point of sales |
Aspen Medical Products Malaysia Sdn Bhd |
7 November 2025 |
|
49 |
Hurix's Cream For Mouth Ulcer Plus (With Aloe Vera) |
MAL21086097TC |
Multiple active ingredients |
M004 250601, M004 250701 |
A complaint was received regarding a quality issue involving a colour change, whereby the product colour was found to be inconsistent with the specified product specification. |
Voluntary recall up to the point of sales |
JIN BIN CORPORATION SDN. BHD. |
25 November 2025 |
|
50 |
Clarem 250 Tablet |
MAL20040981AZ |
Clarithromycin |
113107, 108385 |
CEP for API manufacturer, SM Biomed Sdn. Bhd. was withdrawn by EDQM following non-compliance with GMP during inspection by Belgium authority on the 6th-8th October 2025. |
Voluntary recall up to the point of sales |
Eucogen Sdn. Bhd. |
28 November 2025 |
|
51 |
HEPARINOL 5000 IU/ML |
MAL19870139AZ |
Heparin Sodium |
L22H0035 |
Failed potency limit test (specification: 90-110%) |
Degree I recall up to the point of sales |
AIN MEDICARE SDN. BHD. |
19 December 2025 |
|
52 |
Panadol Menstrual Caplet |
MAL19961356XR |
|
All batches manufactured from February 2024 until December 2025 |
Out-of-specification result was observed for the dissolution parameter for batch XV8R at the 18-month stability study timepoint. As a precautionary measure, the company extends the recall to all batches manufactured from February 2024 until December 2025. |
Voluntary recall up to the point of sales |
Haleon Malaysia Sdn. Bhd. |
22 December 2025 |
|
Last updated 23/04/2026 |
||||||||
Year 2024
|
No |
Product Name |
Registration Number |
Active ingredients |
Batch Number |
Reason for Recall |
Degree and Level of Recall |
Registration Holder |
Date of recall |
|
1 |
Axcel Cimetidine-200 Suspension |
MAL19940272AZ |
Cimetidine 200mg/5ml |
B2305045 |
The assay of cimetidine and preservative sodium benzoate conducted on batch B2305045 with pack size 100mL was found to be out of specifications during real time stability study at 3 and 6 months point. |
Voluntary recall up to the point of sales |
Kotra Pharma (M) SB |
23 January 2024 |
|
2 |
Tenormin Tablet 50mg |
MAL19870055ACZ |
Atenolol 50mg |
6004731 |
label incompliance |
Voluntary recall up to the point of sales |
DKSH Malaysia Sdn Bhd |
01 February 2024 |
|
3 |
Herbanika Barut |
MAL20014435T |
Herbs |
2211351 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count and Total Yeasts and Moulds Count above allowable limit |
Degree III recall up to the point of sales |
MISB Resources Sdn Bhd, Malaysia |
01 February 2024 |
|
4 |
Ubijaga Tongkat Ali Plus |
MAL06021354T |
Herbs |
T354UT30 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count and Bile-Tolerant Gram Negative Bacteria above allowable limit |
Degree III recall up to the point of sales |
Syarikat Zulkifli Bamadhaj, Malaysia |
01 February 2024 |
|
5 |
Kapsul Habbatus Sauda 300mg |
MAL06051554T |
Semen Nigella sativa 300mg |
T308KHS |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Syarikat Zulkifli Bamadhaj, Malaysia |
01 February 2024 |
|
6 |
Vigouroxy |
MAL06091569T |
Herbs |
052205V |
The batch tested by NPRA found to contain Bile-Tolerant Gram Negative Bacteria above allowable limit |
Degree III recall up to the point of sales |
Nature's Grace (M) Sdn Bhd, Malaysia |
01 February 2024 |
|
7 |
Apo-Mometasone Furoate Aqueous Nasal Spray 50 MCG/Metered Spray |
MAL18016032AZ |
Mometasone furoate 50mcg/ metered spray |
TZ2389 |
Potential presence of Burkholderia cepacia complex (BCC) in the affected batch. |
Voluntary recall up to the point of sales |
Pharmaforte (Malaysia) Sdn. Bhd. |
21 February 2024 |
|
8 |
Hyomide Tablet 10mg |
MAL05101675AZ |
Hyoscine butylbromide 10mg |
2107056 |
Failure of related substances (tropic acid) assay test during stability study programme. |
Voluntary recall up to the point of sales |
Duopharma Maufacturing (Bangi) Sdn Bhd |
13 March 2024 |
|
9 |
Listra Habbasauda 500mg Capsules |
MAL16060013TC |
Nigella sativa semen powder 500mg |
TAAAZZAAALB 027-023 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Bina Mutiara Global Sdn Bhd, Malaysia |
14 March 2024 |
|
10 |
viTasential Chlorophyllin Plus Liquid |
MAL18026028N |
Sodium Copper Chlorophyllin 90mg Spirulina (Spirulina platensis) 10mg Chlorella (Chlorella vulgaris) Concentrate 10mg |
VCP0822001 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Sweet Heart Food Industries Sdn Bhd |
14 March 2024 |
|
11 |
Hb" Well Capsule |
MAL16060026TC |
Herbs |
23D1851 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Metro Signature Sdn Bhd |
14 March 2024 |
|
12 |
Wai Yoen Gold Brand Wu Jin Wan (Big Pill) |
MAL21026053T |
Herbs |
03238A |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Nutri-Home Pharmaceutical Industries Sdn Bhd |
25 April 2024 |
|
13 |
Vivital Pharma Zivron Capsule |
MAL16090042TC |
Herbs |
M005C23C |
The batch tested by NPRA found to contain Bile- Tolerant Gram Negative Bacteria above allowable limit |
Degree III recall up to the point of sales |
Ligno & Us Sdn Bhd |
25 April 2024 |
|
14 |
Provin-C Capsule |
MAL21086075T |
Herbs |
2306C0517 |
The batch tested by NPRA found to contain Total Yeasts and Moulds Count above the allowable limit |
Degree III recall up to the point of sales |
Thiallan Bioherbs Sdn Bhd |
25 April 2024 |
|
15 |
Ferrocyte Tablet 50mg |
MAL19920395XZ |
Ferric sodium citrate 50mg |
1) 19A01S 2) 1ZA01S 3) 225A01S 4) 22XA01S 5) 231A01S 6) 235A01S 7) 237A01S 8) 242A01S |
Out of specification for dissolution test at 12 months stored at 30°C/75% RH during annual stability study for batch 22XA01S |
Voluntary recall up to the point of sales |
Eisai (Malaysia) Sdn Bhd |
23 May 2024 |
|
16 |
Pantoprazole Sandoz 40mg Powder for Solution For Injection |
MAL14125125AZ |
Pantoprazole Sodium Sesquihydrate 40mg |
NS0719 |
Formation of visible particles after reconstitution. The particles identification revealed to be a complex of Pantoprazole API adsorbed on siloxane/ silicone particles. |
Voluntary recall up to the point of sales |
Sandoz Products Malaysia Sdn Bhd |
10 June 2024 |
|
17 |
Ilium Ketamil Injection |
MAL15070027HA (for use in animals) |
Ketamine Hydrochloride 100mg/mL |
240130B |
Reports of crystallization in a small number of vials for particular batch (240130B) as informed by the product manufacturer. |
Voluntary recall up to the point of sales |
Delfi Marketing Sdn. Bhd. |
14 June 2024 |
|
18 |
Shanghai Brand Ke Ou Du Tong San |
MAL21096093TC |
Herbs |
SW32-003 |
The batch tested by NPRA found to contain Cadmium above the allowable limit |
Degree II recall up to the point of sales |
Kheng Heng Medical (M) Sdn Bhd, Malaysia |
14 June 2024 |
|
19 |
Dat's San Hong Yoke Wong (Syrup) |
MAL20012968TC |
Herbs |
M0606T06 |
The batch tested by NPRA found to contain Total Yeast and Moulds Count above the allowable limit |
Degree III recall up to the point of sales |
Tat Seo Health Factory Plt, Malaysia |
14 June 2024 |
|
20 |
Tanamera Lemongrass and Ginger Herbal Tea |
MAL16085043TC |
Cymbopogon citratus (caulis) 1g Zingiber officinale (rhizome) 1g |
23A02 |
The batch tested by NPRA found to contain Cadmium above the allowable limit |
Degree II recall up to the point of sales |
Tanamera Tropical Spa Sdn Bhd, Malaysia |
14 June 2024 |
|
21 |
HLP Raven Enema |
MAL06011891XC |
Glycerin 25% v/v Sodium Chloride 15% w/v |
LR01A01 |
The batch tested by NPRA had failed physical appearance test |
Degree III recall up to the point of sales |
Sew Cheong Corporation Sdn Bhd, Malaysia |
14 June 2024 |
|
22 |
OK Kacip Fatimah Plus 500mg |
MAL16040024T |
Multiple active ingredients |
A23024979 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall up to the point of sales |
Perniagaan Orang Kampung Sdn. Bhd. |
14 Jun 2024 |
|
23 |
Queen Jelly |
MAL06011765T |
Royal jelly 228mg |
230701 |
The batch tested by NPRA found to contain Cadmium above the allowable limit |
Degree II recall up to the point of sales |
Yi Wang Honey Garden (M) Sdn Bhd, Malaysia |
18 July 2024 |
|
24 |
Megalive NutriFer Capsule |
MAL18096093NC |
Iron pyrophosphate 230mg (equivalent to 17.94mg Iron) Folic acid 0.9mg Vitamin C 50mg Vitamin B12 0.06mg Copper gluconate 14.28mg (equivalent to 2mg Copper) |
DD0206 |
The batch tested by NPRA had failed assay test for Folic Acid |
Degree III recall up to the point of sales |
Megalive BioSciences Sdn Bhd, Malaysia |
18 July 2024 |
|
25 |
Hurix’s Gamat Plus Syrup |
MAL21036096TC |
Herbs |
• 100mL Syrup Batch Number: • S050 231101 • S050 231201 • S050 231202 • S050 240101 • S050 240102 • S050 240103 • S050 240104 |
Recalls made following several complaints received by the company about the syrup appeared to be foamy after opening the cap which may indicates spoilage. |
Voluntary recall up to the point of sales |
Jin Bin Corporation Sdn. Bhd. |
25 July 2024 |
|
26 |
Hurix’s Sirap Ubat Batuk Untuk Kanak-Kanak |
MAL20033451TC |
Herbs |
• 60mL Syrup Batch Number: • S009 231101 • S009 231102 • S009 231201 • S009 231202 • S009 240101 • S009 240201 |
Recalls made following several complaints received by the company about the syrup appeared to be foamyafter opening the cap which may indicates spoilage. |
Voluntary recall up to the point of sales |
Jin Bin Corporation Sdn. Bhd. |
25 July 2024 |
|
27 |
Powerlife Turmeric Zingiber Ginkgo with Piper Nigrum Tablet |
MAL21026076TC |
Herbs |
DF0147 DF0285 |
The colour of the tablets is different from the registered specification. |
Voluntary recall up to the point of sales |
Powerlife (M) Sdn. Bhd. |
22 August 2024 |
|
28 |
Actimol Suspension 250mg/5mL |
MAL20046151XZ |
Paracetamol |
5031695 |
The assay test for active pharmaceutical ingredient (paracetamol) conducted on the retention sample for batch 5031695 revealed out of specification results. |
Voluntary recall up to the point of sales |
Idaman Pharma Manufacturing Sdn. Bhd. |
27 August 2024 |
|
29 |
Traditional Hou Tsao San |
MAL05092424T |
Multiple active ingredients |
2311-23L05 |
The batch tested by NPRA found to contain cadmium above the specification limit |
Degree III recall up to the point of sales |
Ban Kah Chai Pharmaceutical Sdn. Bhd. |
06 September 2024 |
|
30 |
Ban Kah Chai Gold Brand Cordyceps Luo Han Guo Cough Syrup Plus |
MAL07101292TC |
Herbs |
BN2404/23 BN2405/23 BN2401/24 BN2402/24 |
This recall is being carried out following an out-of- specification result for the volume test conducted on the affected batch. |
Voluntary recall at the point of sub-distributor (wholesaler) |
Ban Kah Chai Pharmaceutical Sdn. Bhd., Malaysia |
4 October 2024 |
|
31 |
Pharmaniaga Enalapril Tablet 5mg |
MAL20034480AZ |
Enalapril Maleate 5mg |
5022938 |
Out-of-specification result for the product’s dissolution and related substances test during stability study. |
Voluntary recall up to the point of sales |
Pharmaniaga Manufacturing Berhad |
04 October 2024 |
|
32 |
Pharmaniaga Ephedrine Hydrochloride 30 mg/mL Injection |
MAL19961320AZ |
Ephedrine Hydrochloride 30mg/mL |
5032011 |
This recall is being conducted due to the incorrect expiry date found on the ampoules label of the product. |
Voluntary recall up to the point of sales |
Pharmaniaga Lifescience Sdn. Bhd |
16 October 2024 |
|
33 |
Caslot Tablets 25mg |
MAL05090004AZ |
Carvedilol 25mg |
22010014 |
This recall is being conducted due to an out-of-specification result for the product's dissolution test during stability study. |
Voluntary recall up to the point of sales |
Ranbaxy (Malaysia) Sdn. Bhd. |
18 October 2024 |
|
34 |
Ubat Akar-Akar Teh Sejuk Cap Tan Ngan Lo 6G/ Bag |
MAL19950944T |
Multiple active ingredients |
BCC021A |
This recall is being conducted due to the batch tested and found to contain cadmium above allowable limit |
Voluntary recall up to the point of sales |
Wen Jiang Medical Industries Sdn Bhd |
30 October 2024 |
|
35 |
Apo-Amitriptyline 10mg Tablet |
MAL19984714ARZ |
Amitriptylline Hydrochloride |
TW2842 |
The recall is being carried out following the decision regarding the content of N-nitroso-nortriptyline (NNORT) reported by Health Canada for batch TF8586, TF8587 and TF8589. The additional batches (TW2842) are recalled as a precautionary measure. |
Voluntary recall up to the point of sales |
Pharmaforte (Malaysia) Sdn. Bhd. |
30 October 2024 |
|
36 |
Tai Fong Headache & Toothache Capsule |
MAL05051145TC |
Multiple active ingredients |
T1222C50 |
This recall is being conducted due to the batch tested and found to contain cadmium above allowable limit |
Degree II recall up to the point of sales |
Smart Wellmin Sdn Bhd |
21 November 2024 |
|
37 |
Beprosalic Lotion |
MAL20021135AZ |
Betamethasone dipropianate 0.064% Salicylic acid/ 2-Hydroxybenzoic acid 2.0% |
1) 03913408 2) 06665408 3) 05094408 4) 1167B308 5) 01512408 |
This recall is being conducted due to an out-of- specification result for content of active pharmaceutical ingredient and appearance during stability study. |
Voluntary recall at the point of sub-distributor (wholesaler) |
Hoe Pharmaceuticals Sdn. Bhd. |
03 December 2024 |
|
38 |
Soluwax Ear Drops |
MAL19911464X |
Docusate sodium 0.5% w/v |
1) 06635404 2) 05595404 |
This recall is being conducted due to an out-of- specification result for pH parameter during stability study. |
Voluntary recall at the point of sub-distributor (wholesaler) |
Hoe Pharmaceuticals Sdn. Bhd. |
03 December 2024 |
|
39 |
Etoxib F.C. Tablet 60mg |
MAL22076022AZ |
Etoricoxib 60mg |
TE210035 |
An out of specification result was observed in the physical appearance test at the 12-month point of the stability study. |
Voluntary recall up to the point of sales |
Medispec (M) Sdn. Bhd. |
03 December 2024 |
|
40 |
YSP Allopurinol Tablet 300mg |
MAL19992398AZ |
Allopurinol 300mg |
1) ALT3 2) IC005 3) IC006 4) IC007 5) IC008 6) IC009 7) ID010 |
This recall is being conducted due to an out-of-specification result for the product’s colour and appearance. |
Voluntary recall up to the point of sales |
Y.S.P. Industries (M) Sdn. Bhd. |
10 December 2024 |
|
41 |
Fenadium Tablet 25mg |
MAL19900395AZ |
Diclofenac sodium 25mg |
627-22001 |
This recall is being conducted due to an out-of-specification result for the product’s other unspecified impurities during stability study |
Voluntary recall up to the point of sales |
Sunward Pharmaceutical Sdn. Bhd. |
20 December 2024 |
Last update : 07/07/2025
Year 2023
| No | Product Name | Registration Number | Active Ingredients | Batch Number | Reason for Recall | Degree and Level of Recall | Registration Holder | Date of Recall |
| 1 |
Storvas C 20mg tablet |
MAL11060016AZ |
Atorvastatin |
19121372 20040326 21010027 |
Out of specification of “Any Individual Impurity” in Related Substance Test of the product |
Voluntary recall at the point of sales |
Ranbaxy (Malaysia) Sdn Bhd |
06 January 2023 |
| 2 |
Storvas C 40mg tablet |
MAL11060017AZ |
Atorvastatin |
19121375 |
Out of specification of “Any Individual Impurity” in Related Substance Test of the product |
Voluntary recall at the point of sales |
Ranbaxy (Malaysia) Sdn Bhd |
16 January 2023 |
| 3 |
Hermosa Maca 500mg
|
MAL20086112TC |
Radix Lepidium meyenii 500mg |
T0121T01 | The batch tested by NPRA found to contain Cadmium above allowable limit |
Degree II recall at the point of sales |
Ecorigin Plt | 17 January 2023 |
| 4 |
Xetec Tablet 10mg
|
MAL20040625AZ |
Cetirizine Dihydrochloride 10mg |
XE 20L 001 |
The batch tested by NPRA failed dissolution test and found to contain any secondary peak and Total impurities above specification limit |
Degree II recall at the point of sales |
SM Pharmaceuticals Sdn Bhd | 17 January 2023 |
| 5 |
Gabata 300 (Gabapentin Capsules USP 300mg) |
MAL19016037AZ |
Gabapentin 300mg |
21145468 20141660 |
Out of specification for “Any other individual impurities” was reported during stability study testing |
Voluntary recall at the point of sales |
Ascend Laboratories Sdn. Bhd. | 08 February 2023 |
| 6 |
Bravecto 1400mg Chewable tablet for large dogs |
MAL20026086HAR |
Fluralaner 1400mg Chewable Tablet |
22M5075A01 |
Label incompliance |
Voluntary recall at the point of sales |
Intervet (M) Sdn. Bhd. |
09 February 2023 |
| 7 |
|
MAL20116092TC |
Multiple active ingredients (Herbs) |
22A007 |
The batch tested by NPRA found to contain Total Aerobic Microbial Count, Total Yeasts and Moulds Count and Bile-Tolerant Gram Negative Bacteria above allowable limit |
|
Chai Teck Sang Medical Hall Sdn Bhd |
28 February 2023 |
| 8 |
WHP Modified Lian Hua Qing Wen Capsule |
MAL21056079T |
Multiple active ingredients (Herbs) |
220315 |
The batch tested by NPRA found to contain cadmium and lead above the allowable limit |
Degree II recall at the point of sales |
White Heron Pharmaceutical Sdn. Bhd. | 28 February 2023 |
| 9 |
Actimol Suspension 250mg/5mL |
MAL20046151XZ |
Paracetamol |
5026851 |
Out of specification for assay during accelerated and real time stability study testing |
Voluntary recall at the point of sales |
Idaman Pharma Manufacturing Sdn. Bhd. | 17 March 2023 |
| 10 |
Duro-Tuss Regular Cough Liquid 1mg/mL |
MAL13025049ACZ |
Pholcodine 1mg/1mL |
All batches
|
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)
|
Degree II recall from all consumers (end users) |
Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch
|
20 March 2023 |
| 11 |
Duro-Tuss Forte Cough Liquid 3mg/mL |
MAL13025050ACZ |
Pholcodine 3mg/ 1mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch |
20 March 2023 |
| 12 |
Duro-Tuss Expectorant Cough Liquid |
MAL13025051ACZ |
Pholcodine 1mg /1mL Bromhexine HCl 0.8mg/ 1mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch |
20 March 2023 |
| 13 |
Difflam Anti-Inflammatory Antibacterial Lozenges With Cough Suppressant |
MAL14075076ACZ |
Pholcodine 5.5mg Benzydamine hydrochloride 1.5mg Cetylpyridinium Chloride 1.33mg |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch |
20 March 2023 |
| 14 |
Russedyl Compound Linctus |
MAL14055155AZ |
Pholcodine 5mg/ 5mL Phenylephrine Hydrochloride 10mg/ 5mL Promethazine Hydrochloride 3.6mg/ 5mL
|
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Pharmaniaga Manufacturing Berhad | 20 March 2023 |
| 15 |
Promedyl Plus Linctus |
MAL20033514AZ |
Pholcodine 10mg/ 5mL Chlorpheniramine Maleate 4mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Duopharma Marketing Sdn. Bhd. | 20 March 2023 |
| 16 |
Pholcodyl Syrup |
MAL05072033AZ |
Pholcodine 5mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Sunward Pharmaceutical Sdn. Bhd.
|
20 March 2023 |
| 17 |
Pholcodyl Forte Syrup |
MAL05072034AZ |
Pholcodine 15mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Sunward Pharmaceutical Sdn. Bhd. |
20 March 2023 |
| 18 |
Rhynacol F Syrup |
MAL08010750AZ |
Pholcodine 15mg/ 5mL Triprolidene Hydrochloride 2.5mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Sunward Pharmaceutical Sdn. Bhd. |
20 March 2023 |
| 19 |
Ducodin Forte Linctus 15mg/5mL |
MAL07101250AZ |
Pholcodine 15mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Hovid Berhad
|
20 March 2023 |
| 20 |
Ducodin Linctus 5mg/5mL |
MAL07101251AZ |
Pholcodine 5mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Hovid Berhad | 20 March 2023 |
| 21 |
Tussedyl Forte Syrup 15mg/5mL |
MAL06121115AZ |
Pholcodine 15mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Pahang Pharmacy Sdn. Bhd. | 20 March 2023 |
| 22 |
Axcel Iridin Linctus |
MAL09020970AZ |
Pholcodine 10mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Kotra Pharma (M) Sdn. Bhd.
|
20 March 2023 |
| 23 |
Axcel Iridin Plus Linctus |
MAL09051551AZ |
Pholcodine 5mg/ 5mL |
All batches |
The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA) |
Degree II recall from all consumers (end users) |
Kotra Pharma (M) Sdn. Bhd. | 20 March 2023 |
| 24 | Zyrtec-D Tablet |
MAL06061671ARZ |
Cetirizine dihydrochloride and Pseudoephedrine hydrochloride |
321907 |
Packaging defect |
Voluntary recall at the consumer level (end users) |
GlaxoSmithKline Pharmaceutical Sdn. Bhd. |
29 March 2023 |
| 25 |
Moxied CLV Injection 600mg |
MAL20041268AZ |
Amoxycillin sodium 500mg, Potassium clavulanate 100mg |
APE204 |
Out of specification observed during routine viable environmental monitoring |
Voluntary recall at the point of sales |
SM Pharmaceuticals Sdn. Bhd. | 05 May 2023 |
| 26 |
Moxied CLV Injection 1.2g |
MAL20041269AZ |
Amoxycillin sodium 1000mg, Potassium clavulanate 200mg |
API101 API204 |
Out of specification observed during routine viable environmental monitoring |
Voluntary recall at the point of sales |
SM Pharmaceuticals Sdn. Bhd. | 05 May 2023 |
| 27 |
Mesporin-1000 I.V. Vials |
MAL20013996ACZ |
Ceftriaxone |
Z0027Z0054 Z0108Z0125 |
Detection of visible particles in the reconstituted powder |
Voluntary recall at the point of sales |
Mepharm (Malaysia) Sdn. Bhd. | 17 May 2023 |
| 28 |
Eno Fruit Salt Lemon |
MAL19962147XR |
Sodium bicarbonate, Citric acid, Sodium carbonate |
XT4E |
The impacted batch may potentially be contaminated with foreign materials |
Voluntary recall at the distributor level |
GlaxoSmithKline Consumer Healthcare Sdn. Bhd. | 14 June 2023 |
| 29 |
Ecort cream |
MAL19913384AZ |
Econazole nitrate 1% w/w and triamcinolone 0.1% w/w |
23E1470 |
Label incompliance |
Voluntary recall at the point of sales |
Dynapharm (M) Sdn. Bhd. | 23 June 2023 |
| 30 |
Holistica Coflix Liquid |
MAL20116054TC |
Multiple active ingredients (Herbs) |
7228221221B |
There is a risk of glass fragment present in the bottle of the product |
Voluntary recall at the consumer level (end users) |
Eldon Healthcare Sdn. Bhd. | 27 June 2023 |
| 31 |
Sabril 500mg Tablet |
MAL19961357AZ |
Vigabatrin 500mg |
2991A |
Detection of traces of tiapride originated from API vigabatrin |
Voluntary recall at the point of sales |
Sanofi-Aventis (Malaysia) Sdn. Bhd. | 18 July 2023 |
| 32 | Apo-acyclovir 400mg | MAL19984322ARZ | Acyclovir 400mg | TH6095 |
Impurity N-nitrosodimethylamine (NDMA) was found to exceed the acceptable intake limit in batch TH6095 |
Voluntary recall at the point of sales |
Pharmaforte (Malaysia) Sdn. Bhd. |
18 August 2023 |
| 33 |
Apo-acyclovir 800mg |
MAL19984323ARZ |
Acyclovir 800mg |
TK3920 |
Following voluntary recall of Apo-acyclovir 400mg (batch TH6095), as a precautionary measure, the company extends the recall to include two additional batches, TK3920 and TF4478 |
Voluntary recall at the point of sales |
Pharmaforte (Malaysia) Sdn. Bhd. | 18 August 2023 |
| 34 |
Alesone Cream |
MAL20040076AZ | Mometasone furoate 0.1% w/w | E2104043 | The batch tested by NPRA failed assay test for Mometasone furoate |
Degree II recall at the point of sales | Prime Pharmaceutical Sdn Bhd | 28 February 2023 |
| 35 | Li Zhong Tang Extract Powder “Sheng Chang” | MAL10012457T | Herbs | CP3411210 | The batch tested by NPRA found to contain Bile-Tolerant Gram Negative Bacteria above allowable limit |
Degree III recall at the point of sales | Lifecare Essential Sdn Bhd | 28 February 2023 |
| 36 |
Lartil Injection 1mL (12.5 mg/mL) |
MAL19970964AZ | Prochlorperazine Mesylate 12.5mg /1 ml | 212603L | The batch tested by NPRA found to contain related substances that were out of specification limit |
Degree II recall at the point of sales | Duopharma (M) Sdn Bhd | 28 February 2023 |
| 37 |
Ke Ou Du Tong San (kim Loong Brand) |
MAL20000959TC | Herbs | 2202-22B20 | The batch tested by NPRA found to contain cadmium above allowable limit |
Degree II recall at the point of sales | Jin Loong Enterprise Sdn Bhd | 28 February 2023 |
| 38 |
Ubat akar-akar the sejuk cap Tan Ngan Lo 6g/bag |
MAL19950944T | Herbs | BBCT721 | The batch tested by NPRA found to contain cadmium above allowable limit |
Degree II recall at the point of sales | Wen Jiang Medical Industries Sdn Bhd | 28 February 2023 |
| 39 |
Chuan Pei Plus Powder Shanghai Brand |
MAL20076113TC | Herbs | 22B7002 | The batch tested by NPRA found to contain Bile-Tolerant Gram-Negative Bacteria above allowable limit |
Degree III recall at the point of sales | Keng Heng Medical (M) Sdn Bhd | 11 April 2023 |
| 40 |
Skin-Fix cream |
MAL15070014TC | Channa striatus extract 4g | 22SC02 | The batch tested by NPRA found to contain Total Yeasts and Moulds Count above allowable limit |
Degree III recall at the point of sales | Truelifesciences Holdings Sdn Bhd | 11 April 2023 |
| 41 |
Throat Medicated Powder |
MAL05023417T | Herbs | 073220401 | The batch tested by NPRA found to contain cadmium and lead above allowable limit |
Degree II recall at the point of sales | Herbal Land Manufacturing Sdn Bhd | 11 April 2023 |
| 42 |
Nutri-Home Chin Choo Watermelon Frost Plus 2.2gm |
MAL20001664T | Herbs | 09208A | The batch tested by NPRA found to contain cadmium and Total Aerobic Microbial Count above allowable limit | Degree II recall at the point of sales | Nutri-Home Pharmaceutical Industries Sdn Bhd | 11 April 2023 |
| 43 | Golf Tong Jin Wan | MAL05121297T | Herbs | 22B8010 | The batch tested by NPRA found to contain cadmium above allowable limit |
Degree II recall at the point of sales | Shanghai Chatlin Pharmaceutical Company | 14 July 2023 |
| 44 | Musclesmooth Herbal Plaster | MAL10100092T | Herbs | MUPUURA001 | The batch tested by NPRA found to contain cadmium above allowable limit |
Degree II recall at the point of sales | Sun Ten Pharmaceutical Mfg (M) Sdn Bhd | 14 July 2023 |
| 45 | Yung Kien Ganoderma 2 capsules | MAL10120091T | Extract of Ganoderma tsugae fruit body 450mg | A2BH291 | The batch tested by NPRA found to contain cadmium above allowable limit |
Degree II recall at the point of sales | Shuang Hor Enterprise (M) Sdn Bhd | 14 July 2023 |
| 46 | Dynalexin dry syrup 125mg/5ml | MAL07031083AZ | Cephalexin monohydrate | 22S2374 | Packaging defect | Voluntary recall at the point of sales | Dynapharm (M) Sdn. Bhd | 08 August 2023 |
| 47 | Guo Ma Ba Bao San (Powder) | MAL19988658T | Herbs | BBS2302 | The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall at the point of sales | Shin Li Trading | 24 August 2023 |
| 48 |
Phytosophy Phyto Chlorophyll Plus Liquid
|
MAL16070029T | Chlorophyll powder 120mg Chlorella pyrenoidosa 40mg Potassium sorbate 0.03% |
PTC 1400 | The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit | Degree III recall at the point of sales | PHHP Group Sdn Bhd | 24 August 2023 |
| 49 | Shafli Teh Herba Gaharu | MAL13115169T | Folium Aquilaria malaccensis 1.5g | GT1001-0323 | The batch tested by NPRA found to contain Cadmium above allowable limit |
Degree II recall at the point of sales | Shafli Lagenda Sdn Bhd | 22 September 2023 |
| 50 | Alfa-D 1.00mcg Capsule | MAL09061594X | Alfacalcidol 1.00 mcg | 22E72 & 22E73 | The assay for Alfacalcidol conducted on batch 22E72 & 22E73 was found to be out of specifications during real time stability study at 12 months point |
Voluntary recall at the point of sales | Pahang Pharmacy Sdn Bhd | 27 September 2023 |
| 51 | Di Ann Du Tong San | MAL20032112T | Herbs | All batches | The batch tested by NPRA found to contain Total Aerobic Microbial Count (TAMC) above allowable limit |
Degree III recall at the point of sales | Di Ann Trading | 01 November 2023 |
| 52 | Honesty Healthcare American Ginseng 300 mg capsule | MAL05051191TC | Radix Panax quinquefolium L. 300mg | 220108 | The batch tested by NPRA found to contain cadmium above allowable limit |
Degree II recall at the point of sales | Conforer Medi-Care Enterprise | 01 November 2023 |
| 53 | Wykon Xiao Er Bao Yin San | MAL21116118TC | Herbs | WBY22L01E | The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall at the point of sales | Wykon Medical Sdn Bhd | 01 November 2023 |
| 54 | IME-9 Tablets | MAL21016096T | Herbs | 157 | The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall at the point of sales | Ayush 82 Resources | 01 November 2023 |
| 55 | Omiflu Capsule 75mg | MAL07090926AZ | Oseltamivir phosphate | 200879L | Failure of organic impurities and assay test during stability study programme |
Voluntary recall at the point of sales | Duopharma (M) Sdn Bhd | 17 November 2023 |
| 56 | Ekoplast Medicated Plaster | MAL21096001XC | Ginger oil 4% w/w Methyl salicylate 4% w/w Menthol 2.5% w/w Camphor 1.8% w/w |
V2212008 | The batch tested by NPRA failed assay test for Methyl Salicylate | Degree III recall at the point of sales | Ee Koh Enterprise Sdn Bhd | 20 December 2023 |
| 57 | Shou Hsing Brand BuYao Pill (small) | MAL16120044TC | Herbs | 9171220722 | The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall at the point of sales | Chua Tongsan Sdn Bhd | 20 December 2023 |
| 58 | Greenherbs Cough with Honey for kids liquid | MAL16080050T | Herbs | 9165221214 | The batch tested by NPRA found to contain Total Aerobic Microbial Count and Total Yeasts and Moulds Count above allowable limit |
Degree III recall at the point of sales | Biofact Life Sdn Bhd | 20 December 2023 |
| 59 | Makjun Seri Perisai | MAL20012966T | Herbs | SP220501 | The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit |
Degree III recall at the point of sales | Syarikat Mutiara | 20 December 2023 |