FDA Class II · Drug · August 12, 2026
Mirabegron Extended-Release Tablets recall — Zydus Pharmaceuticals (USA) Inc
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Official ID D-0745-2026 · Official record ↗
3 recent recalls on record for Zydus Pharmaceuticals (USA) in connected official government data as of September 7, 2026 at 6:00 AM UTC.
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Official ID D-0745-2026 · Official record ↗
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Official ID D-0545-2026 · Official record ↗
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Official ID D-0544-2026 · Official record ↗
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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.