Mirabegron Tablet, Extended Release
FDA Recall NDC 70710-1160
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mirabegron (NDC 70710-1160). A significant event, classified as Class II, was initiated on Aug 05, 2026 by Zydus Pharmaceuticals (usa) Inc.. The reported reason for this action was: "CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Aug 05, 2026
Aug 12, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99563
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Affected Packages Involved in this Recall
70710-1159-3Product
70710-1159-9Product
70710-1159-1Product
70710-1160-3Product
70710-1160-9Product
70710-1160-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
