FDA Recall D-0459-2025

Alembic Pharmaceuticals Limited

Class II Ongoing 370 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71

Lot / code: Batch 2405014780, Exp. Date: Sep. 30, 2027

Quantity: 2,946 500-count bottles

Reason for recall

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

Recall record

Recall number: D-0459-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide and in PR
Recall initiated: 2025-05-09
Classified by FDA Center: 2025-06-06
FDA published: 2025-06-18
Recalling firm: Alembic Pharmaceuticals Limited

Drug identification

Brand name(s): CELECOXIB
Generic name(s): CELECOXIB
Manufacturer(s): Alembic Pharmaceuticals Inc.
NDC(s): 62332-140, 62332-141, 62332-142, 62332-143
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

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

‹ All recalls