FDA Recall D-0248-2026

Alembic Pharmaceuticals Limited

Class III Ongoing 149 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot# 2405003360, Exp Date: Jan 31, 2026

Reason for recall

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

Recall record

Recall number: D-0248-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: US Nationwide and PR.
Recall initiated: 2025-12-16
Classified by FDA Center: 2026-01-02
FDA published: 2026-01-14
Recalling firm: Alembic Pharmaceuticals Limited

Drug identification

Brand name(s): FESOTERODINE FUMARATE
Generic name(s): FESOTERODINE FUMARATE
Manufacturer(s): Alembic Pharmaceuticals Inc.
NDC(s): 62332-175, 62332-176
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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