The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0067-2021·Announced 2020-11-11

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

Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because the NDMA impurity level exceeds acceptable intake limits.

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 the presence of NDMA above acceptable intake levels represents a significant health risk, meeting the criteria for a Severe rating.

Plain-English summary

Nostrum Laboratories, Inc. is recalling 12,967 bottles of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (NDC 29033-056-01). The affected products are 100-count bottles marked with lot codes MET200101 and MET200301, with an expiration date of 05/2022. The recall is nationwide.

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

Consumers and healthcare providers should stop using the affected medication and contact their healthcare provider for guidance on alternative treatment options. Patients should not discontinue their medication without consulting a healthcare professional.

The recalled product

Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, 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
12,967

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)

  • MET200101
  • MET200301 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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