The Recall Desk
SevereFDA (Drugs)·D-1344-2020·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.

What this means for you

Illness, injury, or structural failure has been reported. 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 involves a potential carcinogen (NDMA) above acceptable intake levels, which aligns with the 'Severe' criteria for significant health risks.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Metformin Hydrochloride Extended-release Tablets, USP 500 mg. The recall involves bottles of 90 tablets manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ. The products are identified by NDC 65162-178-09 and specific lot codes listed in the recall notice.

The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. NDMA is a potential carcinogen, and the presence of this impurity above acceptable levels constitutes a CGMP (Current Good Manufacturing Practice) deviation. The agency classification for this recall is Class II.

The recall is distributed nationwide. Consumers and healthcare providers should stop using the affected products and contact their healthcare provider for a replacement or alternative treatment. Patients should not discontinue their medication without consulting their healthcare provider.

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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