Alembic Pharmaceuticals Limited: Drug Recall

Recall #D-0459-2025 · 05/09/2025

Class II: Risk

Recall Details

Recall Number
D-0459-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Alembic Pharmaceuticals Limited
Status
Ongoing
Date Initiated
05/09/2025
Location
Panchmahal, India
Voluntary/Mandated
Voluntary: Firm initiated
Product 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

Product Description

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

Distribution Pattern

Distributed Nationwide and in PR

Other Recalls by Alembic Pharmaceuticals Limited

View all recalls by Alembic Pharmaceuticals Limited →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.