Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate
- Recalling company
- Alembic Pharmaceuticals Limited
- Product
- 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
- Reason
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Dec 16, 2025
- Reported
- Jan 14, 2026
- Distribution
- US Nationwide and PR.
- Status
- Ongoing
- Lot / codes
- Lot# 2405003360, Exp Date: Jan 31, 2026
- Company location
- Panchmahal
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0248-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0248-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.