Mirabegron Extended-Release Tablets, 25 mg recall — Zydus Pharmaceuticals (usa) Inc (Class II)

Regulatory snapshot

Reason reported by FDA

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

12 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

7 identifying values matched by exact pattern in the 28-word product description above; each is a literal substring of it.

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. Match a package against 70710-1159-3 at the FDA source to confirm it is covered.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Zydus Pharmaceuticals (usa) Inc (3 indexed records) aggregates this firm across datasets.

• What a Class II recall means
• What "Ongoing" recall status means
• How to search FDA drug recalls by NDC
• How to monitor a manufacturer’s recall history

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0745-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.