The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1303-2020·Announced 2020-06-24

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.

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