Alembic Pharmaceuticals Limited recalls
8 federal recalls on file, showing the 3 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Alembic Pharmaceuticals Limited and put it in plain English.
Recent recalls
Alembic bromfenac eye drops recalled for failed impurity testingAlembic Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.07% because the medication failed purity and degradation tests during stability testing at 20 months. The affected eye drops may contain higher-than-acceptable impurity levels, which could affect safety and effectiveness.
ModerateFDAApr 8, 2026
- Alembic fesoterodine tablets recalled for impurity level above limit
Alembic Pharmaceuticals is recalling one lot of Fesoterodine Fumarate 8 mg extended-release tablets because testing found levels of a chemical impurity (diester impurity) that exceed safety limits. The affected lot is 2405003360, which expires January 31, 2026.
ModerateFDAJan 14, 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
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
FDANov 26, 2025