FDAFDA · Food and drugs·Recall number D-0156-2026
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
Published November 26, 2025 · Recall initiated: October 10, 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 · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- FESOTERODINE FUMARATE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Distributor
- Nationwide in the USA.
- UPC
- 0362332176304
- Lot
- Lot # 2405006633, Exp Date: 03/31/2026
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- India
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