Why it was recalled
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
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.
Lot numbers, UPCs & expiration codes
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0745-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 5, 2026
- FDA report date
- Aug 12, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0745-2026, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99563
- Address
- 73 Route 31 N
- Code information
- Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Postal code
- 08534-3601
- Report date
- Aug 12, 2026
- Product type
- Drugs
- Recall number
- D-0745-2026
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Reason for recall
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 5, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2026