The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1345-2020·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) above acceptable intake levels.

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, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as NDMA impurity) are rated as Severe (4), particularly when not explicitly stated as having no reported illness but involving a known hazardous impurity.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Metformin Hydrochloride Extended-release Tablets, USP, 500 mg. The recall involves bottles of 500 tablets manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ. The affected product is identified by NDC 65162-178-50 and specific lot codes listed in the recall notice.

The recall was initiated because FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot codes and NDC numbers listed in the official recall notice. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they are currently taking this medication.

The recalled product

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