US Drug Recall Register
Class II · Moderate risk Ongoing Initiated May 9, 2025 (16 months ago)

Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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

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

Recalling firm
Alembic Pharmaceuticals Limited
NDC code
62332-142-71
Origin
India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0459-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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