Recalls / Class II
Class IID-0459-2025
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
- Brand name
- Celecoxib
- Generic name
- Celecoxib
- Active ingredient
- Celecoxib
- Route
- Oral
- NDCs
- 62332-140, 62332-141, 62332-142, 62332-143
- FDA application
- ANDA204519
- Affected lot / code info
- Batch 2405014780, Exp. Date: Sep. 30, 2027
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
Recalling firm
- Firm
- Alembic Pharmaceuticals Limited
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, N/A, India
Distribution
- Quantity
- 2,946 500-count bottles
- Distribution pattern
- Distributed Nationwide and in PR
Timeline
- Recall initiated
- 2025-05-09
- FDA classified
- 2025-06-06
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0459-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.