The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1347-2020·Announced 2020-07-01

Amneal Recalls Metformin Hydrochloride Tablets Due to 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 like NDMA impurities.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Metformin Hydrochloride Extended-release Tablets, USP, 500 mg. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA. Specifically, FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level.

The affected product is distributed nationwide. The recall covers specific lot numbers and expiration dates listed in the official recall notice, ranging from September 2020 to February 2022. The product is a prescription-only medication manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
Amneal Pharmaceuticals of New York, LLC
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (2)

  • 0365162178104
  • 0365162179101

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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