Alembic Pharmaceuticals Limited
8 federal recalls on file, showing the 3 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Alembic Pharmaceuticals Limited and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-08FDA-DrugClass IIStop using Alembic Bromfenac eye drops
Alembic 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.
- 2026-01-14FDA-DrugClass IIIStop using Alembic Fesoterodine Fumarate tablets
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.
- 2025-11-26FDA-DrugClass IIIFesoterodine 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.
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