Zydus Pharmaceuticals (USA)

1 recall on record · Last recall: Aug 5, 2026

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Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious

Class II — Moderate

Class III — Low Risk

Recall Timeline

Class IIFDAAug 5, 2026

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

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

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