Reported Jan 14, 2026 · Ongoing
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals…
Alembic Pharmaceuticals Limited
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alembic Pharmaceuticals Limited · Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol · Panchmahal · N/A
Is this the product you have?
- Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only
- Manufactured byAlembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India
- Manufactured forAlembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
- Lot codes and dates
- Lot# 2405003360
- Exp Date
Jan 312026
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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