Apotex Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Apotex Inc. is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves the detection of a potential carcinogen (NDMA) above acceptable intake levels, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Apotex Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles. The recall involves 305,963 bottles distributed nationwide. The product is identified by NDC 60505-0260-1 and includes all lots remaining within expiry.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) at levels above acceptable intake limits. NDMA is a potential carcinogen.
Consumers with this medication should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II.
The recalled product
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 305,963
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Apotex Inc.
See all →- SevereApotex Recalls Walgreens Wal-Zan 75 Tablets Due to NDMA Contamination
FDA (Drugs) · 2019-11-20
- SevereRite Aid Ranitidine Tablets Recalled for Possible NDMA Contamination
FDA (Drugs) · 2019-11-20
- SevereApotex Recalls Walgreens Wal-Zan 150 Tablets Due to NDMA Contamination Risk
FDA (Drugs) · 2019-11-20
- SevereApotex Recalls Equate Ranitidine Tablets Due to NDMA Contamination
FDA (Drugs) · 2019-11-20
- SevereRite Aid Ranitidine Tablets Recalled for Potential NDMA Contamination
FDA (Drugs) · 2019-11-20
Same hazard · ndma impurity
See all →- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets
FDA (Drugs) · 2021-05-26
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-02-10
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-01-20
- SevereDenton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SevereDirect Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
FDA (Drugs) · 2020-11-11