Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
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, which corresponds to a 'Severe' rating under the rubric for significant potential health risks such as carcinogenic impurities.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablet bottles (NDC 53746-0178-10). The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.
The FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) at levels above the acceptable intake limit. The affected product was distributed nationwide. Specific lot codes and expiration dates associated with this recall include HF08618A, HF08718A, HF15418A, HF15518A, HH11818A, HJ00818A, HJ00918A, and HJ01018A.
Consumers should check their medication bottles for the NDC 53746-0178-10 and the lot codes listed above. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.
The recalled product
- Product
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug — Prescription Medication
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Amneal Pharmaceuticals of New York, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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