Recall RadarMirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (US…
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Zydus Pharmaceuticals (USA) Inc — Pennington, NJ
- Severity
- Class II — moderate
- Reported
- August 12, 2026
- Recall number
- D-0745-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide in the USA
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