Why it was recalled
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Product description
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Lot numbers, UPCs & expiration codes
Lot #47881, Exp 05/31/2026
Where it was sold
Nationwide in the USA
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-0460-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 13, 2025
- FDA report date
- Jun 18, 2025
- Quantity
- 3,817 50-count cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0460-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96888
- Address
- 615 N 1st St
- Code information
- Lot #47881, Exp 05/31/2026
- Postal code
- 38478-2403
- Report date
- Jun 18, 2025
- Product type
- Drugs
- Recall number
- D-0460-2025
- Classification
- Class II
- Recalling firm
- AvKARE
- Product quantity
- 3,817 50-count cartons
- Reason for recall
- Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 13, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 9, 2025