FDA · Drugs · Wednesday, August 12

Mirabegron Extended-Release Tablets recall

Zydus Pharmaceuticals (USA) Inc recalled Mirabegron Extended-Release Tablets on August 12, 2026 because of cGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. It was sold nationwide.

Why it was recalled

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

What's recalled

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.

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Date: Wednesday, August 12
Severity: Class II
the product could cause temporary or reversible health problems.
Where sold: Nationwide
Nationwide in the USA
Status: Ongoing
Recall number: D-0745-2026
Source: U.S. Food and Drug Administration

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