FDAFDA · Food and drugs·Recall number D-0248-2026
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
Published January 14, 2026 · Recall initiated: December 16, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
What to do
Voluntary: Firm initiated
Recall details
- Brand
- FESOTERODINE FUMARATE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Distributor
- US Nationwide and PR.
- UPC
- 0362332176304
- Lot
- Lot# 2405003360, Exp Date: Jan 31, 2026
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- India
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