Agency classClass IIOur severity:Severe FDA (Drugs)·D-1350-2020·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 potential health risks.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk (NDC 53746-0178-BULK). The recall was initiated after FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) at levels above the acceptable intake limit.

The affected product is distributed nationwide. The recall covers multiple lot codes with expiration dates ranging from June 30, 2020, to February 28, 2021. The source text does not specify the total number of units affected or report any illnesses or injuries associated with the product.

Consumers should check their medication for the specific NDC and lot codes listed in the official recall notice. If the product matches the recalled items, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Category: Drug — Metformin
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