FDARecall 99563Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.
Is it yours? Products and codes
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.
- Lot or code
- Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- FDA recall number
- D-0745-2026
Distribution (FDA): Nationwide in the USA
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.