The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0249-2021·Announced 2021-02-10

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

Nostrum Laboratories is recalling 7,071 bottles of Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains 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 and involves the presence of a known carcinogenic impurity (NDMA) above acceptable levels, which meets the rubric criteria for a Severe rating (FDA Class II with significant health risk).

Plain-English summary

Nostrum Laboratories, Inc. is recalling 7,071 bottles of Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg. The affected product is identified by Lot MET200601 with an expiration date of 07/2022 and NDC 29033-056-01. The recall is due to the detection of the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected tablets were distributed nationwide. This is a prescription-only medication. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or 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 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
7,071

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)

  • Lot MET200601
  • 07/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Nostrum Laboratories Inc

See all →

Same hazard · ndma impurity

See all →

Similar recalls