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Class IIOngoing

Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets

Recall date · record updated Aug 12, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Zydus Pharmaceuticals (USA) Inc
Reason
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Nationwide in the USA
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99563…

Products

  1. 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.

    Codes/lots: Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3Recall no. D-0745-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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