Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Li…

Recall date

December 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0248-2026

FDA classification

Class III

Brand / firm

Alembic Pharmaceuticals Limited

Sold / distributed

US Nationwide and PR.

Why it was recalled

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Class III means the product violates regulations but is not likely to cause harm.

What was 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