August 2026 FDA Recall Mirabegron by Zydus Pharmaceuticals (usa) Inc (D-0745-2026 - CGMP)
This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on August 5, 2026 for the product Mirabegron. The FDA reported the reason for recall as cgmp. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0745-2026
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
08-05-2026
08-12-2026
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
