Zydus Pharmaceuticals (usa) Inc: Mirabegron Extended-release Tablets, 25 Mg, 30-count Bottle
Recall Summary Zydus Pharmaceuticals is recalling 25 mg Mirabegron Extended-Release Tablets (30-count bottles) distributed nationwide because the medication contains higher-than-allowed levels of N-Nitroso Mirabegron, an impurity. This is a Class II recall, meaning use of the product could cause adverse health effects. The recalled tablets were manufactured by Zydus Lifesciences Ltd. in India and distributed across all U.S. states and Washington, D.C.
- Recalling firm
- 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
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-05
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/35d2dcf4-b009-4ad2-bc7b-c1a0b8e4e82b