Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle,
See all recalls from Zydus Pharmaceuticals (USA) Inc →Recalled Product
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
Hazard / Issue
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
✅ 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 Mirabegron Extended-Release Tablets, 25 →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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