FDA recall D-0459-2025

Alembic Pharmaceuticals Limited · Class II · drug

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

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

Distribution

Distributed Nationwide and in PR

Key facts

Status: Ongoing
Initiation date: 2025-05-09
Report date: 2025-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Panchmahal, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0459-2025