FDA Drugs recall ·
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle… recall
- Recall number
- D-0156-2026
- Date
- (initiated October 10, 2025)
- Company / brand
- Alembic Pharmaceuticals Limited
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, India - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 4,884 30-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 2405006633, Exp Date: 03/31/2026
Distribution
Nationwide in the USA.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0156-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.