Agency classClass IIOur severity:Severe FDA (Drugs)·D-1351-2020·Announced 2020-07-01

Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets, 500 mg, 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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant chemical impurities like NDMA that exceed acceptable intake levels.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only. The product is distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ, and carries the NDC 53746-0178-05.

The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. This is classified as a Class II recall by the FDA. The affected lots are identified by the codes HF06618A and HF06718A, both with an expiration date of 6/30/2020.

The distribution pattern for this product is nationwide. Patients and healthcare providers should check their inventory for these specific lot codes and stop using the affected tablets. Consumers should consult their healthcare provider for alternative treatment options or further instructions.

The recalled product

Product: amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Category: Drug — Prescription Medication
Hazard: ndma-impurity
chemical-contamination

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)

HF06618A 6/30/2020 HF06718A 6/30/2020

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 →

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Same hazard · ndma impurity