Recalling firm
Alembic Pharmaceuticals Limited
Product type
Drug
Status
Ongoing
Report date
2025-06-18
Distribution
Distributed Nationwide and in PR
Product quantity
2,946 500-count bottles
Initiated by
Voluntary: Firm initiated
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
Code / lot info
Batch 2405014780, Exp. Date: Sep. 30, 2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.