Fesoterodine Fumarate recall (Alembic Pharmaceuticals Limited)
DrugClass IIIOngoing
Summary: Alembic Pharmaceuticals Limited is recalling 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.
What is being recalled
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
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
US Nationwide and PR. (states named: Puerto Rico)
How to tell if yours is affected
Lot# 2405003360, Exp Date: Jan 31, 2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0248-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | December 16, 2025 |
| Reported | January 14, 2026 |
| Company | Alembic Pharmaceuticals Limited |
| Company location | Panchmahal, India |
| Initiated by | Voluntary: Firm initiated |
More recalls from Alembic Pharmaceuticals Limited · all drug recalls · recalls from December 2025