Agency classClass IIOur severity:Severe FDA (Drugs)·D-1393-2020·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 N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

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, which corresponds to a 'Severe' rating 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, 90 count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level.

The affected product is distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ, and carries the NDC 53746-0178-90. The distribution pattern is listed as nationwide. Specific lot codes and expiration dates are provided in the structured product information, including lots manufactured between June 2020 and March 2021.

Consumers and healthcare providers should stop using the affected product 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, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Category: Drug — Prescription Medication
Hazard: ndma-impurity
carcinogen-exposure

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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Same hazard · ndma impurity