FDA recall D-0248-2026

Product

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 for recall

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

Distribution

US Nationwide and PR.

Key facts

Status

Ongoing

Initiation date

2025-12-16

Report date

2026-01-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Panchmahal, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2026