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
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
Lot numbers, UPCs & expiration codes
Batch 2405014780, Exp. Date: Sep. 30, 2027
Where it was sold
Distributed Nationwide and in PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0459-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 9, 2025
- FDA report date
- Jun 18, 2025
- Quantity
- 2,946 500-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alembic Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-0459-2025, exactly as published.
Show all FDA fields
- City
- Panchmahal
- Status
- Ongoing
- Country
- India
- Event ID
- 96840
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol
- Code information
- Batch 2405014780, Exp. Date: Sep. 30, 2027
- Report date
- Jun 18, 2025
- Product type
- Drugs
- Recall number
- D-0459-2025
- Classification
- Class II
- Recalling firm
- Alembic Pharmaceuticals Limited
- Product quantity
- 2,946 500-count bottles
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide and in PR
- Recall initiation date
- May 9, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2025