PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: June 18, 2025 Initiated: May 9, 2025 #D-0459-2025

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

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

Details

Units Affected
2,946 500-count bottles
Distribution
Distributed Nationwide and in PR
Location
Panchmahal

Frequently Asked Questions

What product was recalled?
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. Recalled by Alembic Pharmaceuticals Limited. Units affected: 2,946 500-count bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Which agency issued this recall?
This recall was issued by the FDA Drug on June 18, 2025. Severity: Moderate. Recall number: D-0459-2025.