The Recall Desk
SevereFDA (Drugs)·D-0392-2022·Announced 2022-02-02

Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination

Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 750 mg tablets due to detection of N-Nitrosodimethylamine (NDMA) at levels exceeding the acceptable daily intake limit. The contamination resulted from manufacturing deviations.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a systemic manufacturing defect (CGMP deviations) that resulted in contamination of an oral prescription drug with a known carcinogenic impurity (NDMA) at levels exceeding regulatory limits. Class II recalls with manufacturing defects in prescription medications warrant a Severe classification.

Plain-English summary

Viona Pharmaceuticals Inc is recalling Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (NDC# 72578-036-01) in 100 count HDPE bottles due to Current Good Manufacturing Practice (CGMP) deviations that led to detection of N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit.

The affected product was distributed to 17 wholesalers who further distributed it to 85 locations. Approximately 238,416 bottles with the following lot codes are involved: M008130, M008131, M008132, M008133, M010080, M010081, M011029, M011030, M011031, M011032, M011304, M013394, M013395, M013396, M013966, M013967, M100831, M100832, M100833, M100834, M101267, M102718, and M102719, with manufacturing dates ranging from June 2022 through January 2023.

Consumers who have this product should stop taking it and contact their healthcare provider or pharmacist. Patients should not discontinue their diabetes medication without consulting their healthcare provider, as this could impact their medical condition.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
VIONA PHARMACEUTICALS INC
Category
Drug — Prescription / Diabetes
Hazard
  • ndma-contamination
  • manufacturing-defect

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 (20)

  • M008130 06/2022
  • M008131 06/2022
  • M008132 06/2022
  • M008133 06/2022
  • M010080 07/2022
  • M010081 07/2022
  • M011029 08/2022
  • M011030 08/2022
  • M011031 08/2022
  • M011032 08/2022
  • M011304 08/2022
  • M013394 09/2022
  • M013395 09/2022
  • M013396 09/2022
  • M013966 09/2022
  • M013967 09/2022
  • M100831 12/2022
  • M100832 12/2022
  • M100833 01/2023
  • M100834 01/2023

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · METFORMIN HYDROCHLORIDE

Same category