Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Metformin Hydrochloride Extended-Release Tablets Recalled by VIONA PHARMACEUTICALS INC Due to CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in...

Date: December 27, 2021
Company: VIONA PHARMACEUTICALS INC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact VIONA PHARMACEUTICALS INC directly.

Affected Products

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

Quantity: 23,8416/100 count bottles

Why Was This Recalled?

CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Where Was This Sold?

Product was distributed to 17 wholesalers who further distributed the product to 85 locations.

About VIONA PHARMACEUTICALS INC

VIONA PHARMACEUTICALS INC has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report