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, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Lot numbers, UPCs & expiration codes
Lot# 2405003360, Exp Date: Jan 31, 2026
Where it was sold
US Nationwide and PR.
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-0248-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Dec 16, 2025
- FDA report date
- Jan 14, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alembic Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-0248-2026, exactly as published.
Show all FDA fields
- City
- Panchmahal
- Status
- Ongoing
- Country
- India
- Event ID
- 98119
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol
- Code information
- Lot# 2405003360, Exp Date: Jan 31, 2026
- Report date
- Jan 14, 2026
- Product type
- Drugs
- Recall number
- D-0248-2026
- Classification
- Class III
- Recalling firm
- Alembic Pharmaceuticals Limited
- 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, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
- Distribution pattern
- US Nationwide and PR.
- Recall initiation date
- Dec 16, 2025
- Center classification date
- Jan 2, 2026