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Zydus Pharmaceuticals (USA) Inc: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Di

DrugsSource: FDA (drug) · Date: 2026-08-12

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Zydus Pharmaceuticals (USA) Inc
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.
Reason / hazard
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-08-05
Code info
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Voluntary mandated
Voluntary: Firm initiated
City
Pennington
State
NJ
Country
United States
Event id
99563
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