Apotex Metformin Tablets Recall: NDMA Impurity Risk
Apotex recalls 500mg extended-release metformin tablets due to NDMA impurity exceeding safe levels. This may pose health risks with long-term use. Consumers should contact Apotex for details.
Lower-risk recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Contact the company
What happened, in plain English
Apotex is recalling 500mg extended-release metformin tablets because they contain unsafe levels of NDMA. This impurity could cause health issues over time, so affected users should stop using the product and contact Apotex. Read more at govinfonow.com/recall/37098-apotex-metformin-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37098-apotex-metformin-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1303-2020
Cite this page
“Apotex Metformin Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37098-apotex-metformin-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-1303-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1303-2020%22&limit=1).
Why it’s dangerous
The tablets contain N-Nitrosodimethylamine (NDMA), a chemical that can form in some medications. FDA testing found unsafe levels of this impurity in the product. Long-term use may pose health risks, but the risk is not immediate or severe.
Who’s affected
People with prescriptions for metformin who own the recalled 500mg extended-release tablets. Those with diabetes are most at risk due to the medication's use.
How to tell if you have this one
Check for Apotex brand metformin tablets labeled 500 mg, 100 count, Rx Only. The product was manufactured by Apotex Inc. in Toronto, Ontario, Canada, with NDC 60505-0260-1.
- Brand
Apotex- Category
Drug
What to do — step by step
Stop Using It Now
Discard the recalled metformin tablets immediately to avoid potential health risks.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1303-2020 (May 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1303-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.