Viona Metformin Tablets Recall: NDMA Levels Exceed Safe Limits
Viona Pharmaceuticals recalls 750mg Metformin Extended-Release Tablets (NDC 72578-036-01) due to detected N-Nitrosodimethylamine (NDMA) levels above safe limits. This medication is prescription-only.
Lower-risk recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Contact the company
What happened, in plain English
Viona Pharmaceuticals is recalling prescription Metformin Hydrochloride Extended-Release Tablets (750mg) manufactured by Cadila Healthcare. The recall is due to N-Nitrosod: a chemical found in excess of safe limits that could pose health risks with long-term use. Read more at govinfonow.com/recall/36128-viona-metformin-tablets-recall-ndma-levels-exceed-safe-limits.
Source Summary by GovInfoNow · govinfonow.com/recall/36128-viona-metformin-tablets-recall-ndma-levels-exceed-safe-limits · Updated August 18, 2026 · FDA enforcement record: FDA #D-0640-2021
Cite this page
“Viona Metformin Tablets Recall: NDMA Levels Exceed Safe Limits.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36128-viona-metformin-tablets-recall-ndma-levels-exceed-safe-limits. Based on FDA recall #D-0640-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0640-2021%22&limit=1).
Why it’s dangerous
N-Nitrosodimethylamine (NDMA) is a chemical that can form in some medications during manufacturing. When detected in excess of safe limits, it may pose health risks with long-term use, though the risk level is considered low for this specific product.
Who’s affected
Prescription patients who received Metformin Hydrochloride Extended-Release Tablets (750mg) with NDC 72578-036-01, Lot M915601 or M915602, manufactured in October 2021. Patients on diabetes medication are most at risk.
How to tell if you have this one
Check your prescription label for 'Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only'. Look for NDC code 72578-036-01 and lots M915601 or M915602 from October 2021.
- Brand
Viona Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Verify your prescription label matches the recalled product description and NDC code.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years 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-0640-2021 (June 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0640-2021 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.