The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1349-2020·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 NDMA impurity 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, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a carcinogenic impurity (NDMA) above acceptable levels.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg. The recall involves prescription bottles containing 100 tablets, manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed by Amneal Pharmaceuticals LLC in New Jersey. The product is identified by NDC 65162-179-10.

The recall was initiated because FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. This is classified as a Current Good Manufacturing Practice (CGMP) deviation. The affected lots are distributed nationwide.

Patients and healthcare providers should check their medication for the specific lot codes listed in the recall notice. If the medication matches the recalled lots, it should not be used. Patients should contact their healthcare provider for guidance on alternative treatment options.

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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