Apotex Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg
See all recalls from Apotex Inc. →Recalled Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
Hazard / Issue
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: All lots remaining within expiry
✅ What Should You Do?
- 1Stop taking this medication and contact your doctor or pharmacist immediately.
- 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
- 3Check the lot number on your bottle or packaging against the recalled lots listed above.
- 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Metformin Hydrochloride Extended-Release Tablets, →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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