The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0640-2021·Announced 2021-06-30

Metformin Hydrochloride Tablets Recalled for NDMA Contamination

Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding acceptable daily 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving detection of a genotoxic impurity (NDMA) without reported illnesses. The hazard presents a potential health risk based on established safety standards, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Viona Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (NDC 72578-036-01) distributed nationwide in the United States. The recall was initiated due to CGMP deviations and detection of N-Nitrosodimethylamine (NDMA) at levels that exceed the FDA's Acceptable Daily Intake Limit.

The affected product consists of 21,240 bottles from Lot M915601 and Lot M915602, manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Viona Pharmaceuticals Inc. in Cranford, New Jersey.

Consumers taking this medication should contact their healthcare provider or pharmacist for guidance. Patients should not stop taking metformin without consulting their healthcare provider, as abrupt discontinuation may affect their diabetes management. Healthcare providers and pharmacists should identify and quarantine affected inventory and notify their wholesalers of the recall.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
VIONA PHARMACEUTICALS INC
Category
Drug — Prescription / Generic
Hazard
Affected units
21,240

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 M915601 & M915602
  • Oct 2021

Distribution

Distributed nationwide across the United States.

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