Agency classClass IIOur severity:Severe FDA (Drugs)·D-1348-2020·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 severity score under the rubric for drug recalls involving significant health risks like NDMA impurities.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets bottles (NDC 53746-0179-01). The recall was initiated because FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level.

The affected product is distributed nationwide. Specific lot codes and expiration dates are listed in the recall documentation, including lots expiring in June 2020 and December 2020.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or alternative treatment options.

The recalled product

Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Category: Drug — Prescription Medication
Hazard: ndma-impurity

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