Alembic Pharmaceuticals Limited recalls Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Di…

Recall date

May 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0459-2025

FDA classification

Class II

Brand / firm

Alembic Pharmaceuticals Limited

Sold / distributed

Distributed Nationwide and in PR

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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