FDA-Drug2026-08-12Class IICHEMICAL
Zydus Mirabegron Extended-Release Tablets recalled for elevated impurity levels
What this means
Zydus Pharmaceuticals is recalling one lot of Mirabegron Extended-Release 25 mg tablets due to higher-than-acceptable levels of N-Nitroso Mirabegron impurity. This impurity can potentially increase long-term health risks with continued use. No injuries have been reported.
- Check if your Mirabegron bottle has lot number E408618 (expiration 11/30/2026).
- Contact your pharmacy or doctor if you have this lot — do not stop taking the medication without guidance.
- Your pharmacy can provide an unaffected replacement or alternative medication.
The agency's original wording
Hazard
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0745-2026Want us to check the next one for you?
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