FDA recall D-0745-2026

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-08-05

Report date

2026-08-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0745-2026