The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0227-2021·Announced 2021-01-20

Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains 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 involves the presence of a carcinogenic impurity (NDMA) above acceptable intake levels, which meets the criteria for a Severe rating due to significant health risk potential.

Plain-English summary

Nostrum Laboratories, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle (NDC: 29033-056-01). The recall involves 6,958 bottles of the prescription medication, which were distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was found to contain the impurity N-Nitrosodimethylamine (NDMA) at levels above the acceptable intake limit. The affected product is identified by the code MET200501 with an expiration date of 07/2022.

Consumers and healthcare providers should stop using the recalled medication and contact their healthcare provider for guidance on alternative treatment options. The recall is classified as FDA Class II.

The recalled product

Product
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
Manufacturer
Nostrum Laboratories Inc
Category
Drug — Prescription Medication
Hazard
Affected units
6,958

Is your product affected?

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

Lot numbers (1)

  • MET200501 07/2022

Distribution

Distributed nationwide across the United States.

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