FDA Drugs recall ·
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets… recall
- Recall number
- D-0248-2026
- Date
- (initiated December 16, 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
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
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# 2405003360, Exp Date: Jan 31, 2026
Distribution
US Nationwide and PR.
States: Puerto Rico
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-0248-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.