Why it was recalled
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Product description
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Lot numbers, UPCs & expiration codes
Lot # 2405006633, Exp Date: 03/31/2026
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-0156-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Oct 10, 2025
- FDA report date
- Nov 26, 2025
- Quantity
- 4,884 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alembic Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-0156-2026, exactly as published.
Show all FDA fields
- City
- Panchmahal
- Status
- Ongoing
- Country
- India
- Event ID
- 97812
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol
- Code information
- Lot # 2405006633, Exp Date: 03/31/2026
- Report date
- Nov 26, 2025
- Product type
- Drugs
- Recall number
- D-0156-2026
- Classification
- Class III
- Recalling firm
- Alembic Pharmaceuticals Limited
- Product quantity
- 4,884 30-count bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Oct 10, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 14, 2025