Reported Aug 12, 2026 · Ongoing
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only
- Manufactured byZydus Lifesciences Ltd., Matoda, Ahmedabad, India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3
- Lot codes and dates
- Lot # E408618
- Expiry
11/30/2026NDC #: 70710-1159-3
Where it was sold
- Nationwide
Why it was recalled
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
This product could cause temporary or reversible health problems — stop using it.
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