Agency classClass IIOur severity:Severe FDA (Drugs)·D-1353-2020·Announced 2020-07-01

Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected 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 agency classification is FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the presence of a carcinogenic impurity (NDMA) above acceptable levels.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, in 1000-tablet bottles. The product is manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India, and distributed by Amneal Pharmaceuticals LLC in Bridgewater, New Jersey. The NDC number is 65162-0178-11.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. The affected lots include lot numbers HF08618A, HF08718A, HF15418A, HF15518A, HH11818A, HJ00818A, HJ00918A, and HJ01018A, with expiration dates ranging from June 30, 2020, to September 30, 2020.

The distribution pattern is listed as nationwide. Consumers should check their medication for the specific NDC and lot numbers listed above. If the product matches the recalled description, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on replacement medication.

The recalled product

Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Category: Drug — Prescription Medication
Hazard: ndma-impurity
cgmp-deviation

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.

See all 12 products in this recall →

Same manufacturer · Amneal Pharmaceuticals of New York, LLC

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