Viona Metformin Tablets Recall: NDMA Levels Exceed Safe Limits
Viona Pharmaceuticals recalls Metformin Hydrochloride Extended-Release Tablets (750mg) due to detected N-Nitrosodimethylamine (NDMA) levels above acceptable limits. Consumers should stop using affected batches.
Stop using this now
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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What happened, in plain English
Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets (750mg) because testing found N-Nitrosodimethylamine (NDMA) levels exceeding safe limits. This could pose a health risk with long-term use, so affected consumers should stop using the product immediately. Read more at govinfonow.com/recall/35416-viona-metformin-tablets-recall-ndma-levels-exceed-safe-limits.
Source Summary by GovInfoNow · govinfonow.com/recall/35416-viona-metformin-tablets-recall-ndma-levels-exceed-safe-limits · Updated August 18, 2026 · FDA enforcement record: FDA #D-0392-2022
Cite this page
“Viona Metformin Tablets Recall: NDMA Levels Exceed Safe Limits.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35416-viona-metformin-tablets-recall-ndma-levels-exceed-safe-limits. Based on FDA recall #D-0392-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0392-2022%22&limit=1).
Why it’s dangerous
NDMA is a potential carcinogen that can form in some medications during manufacturing. The recall occurs because levels of this compound in the affected tablets exceed the acceptable daily intake limit, which could pose health risks with long-term use.
Who’s affected
People who own or use the recalled Metformin Hydrochloride Extended-Release Tablets (750mg) in the specified batch numbers and dates. Those with diabetes who take this medication are most at risk.
How to tell if you have this one
Check for the product name 'Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles' with the NDC number 72578-036-01. Affected batches include specific model numbers and dates listed in the recall notice.
- Brand
Viona Pharmaceuticals- Category
Drug
What to do — step by step
Stop Using Product Now
Immediately stop using the recalled Metformin Hydrochloride Extended-Release Tablets (750mg) if you have them.
How this recall unfolded
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0392-2022 (December 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0392-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.