The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0068-2021·Announced 2020-11-11

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

Nostrum Laboratories is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable 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. The presence of NDMA above acceptable levels represents a significant health risk, though no specific injuries or deaths are reported in the source text.

Plain-English summary

Nostrum Laboratories, Inc. is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles. The product is prescription-only and was distributed nationwide. The specific NDC number is 29033-055-01.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the detection of the impurity N-Nitrosodimethylamine (NDMA) was found above the acceptable intake level. NDMA is a potential carcinogen that can be present in certain pharmaceutical products.

Consumers with this medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The affected lots are identified by the codes MET100201 and MET100401, with an expiration date of 05/2022.

The recalled product

Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
Manufacturer
Nostrum Laboratories Inc
Category
Drug — Prescription Medication
Hazard
Affected units
20,872

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 (2)

  • MET100201
  • MET100401 EXP 05/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Nostrum Laboratories Inc 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 2 products in this recall →

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