Recalls / Class II
Class IID-0460-2025
Product
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
- Brand name
- Celecoxib
- Generic name
- Celecoxib
- Active ingredient
- Celecoxib
- Route
- Oral
- NDCs
- 50268-168, 50268-169
- FDA application
- ANDA204519
- Affected lot / code info
- Lot #47881, Exp 05/31/2026
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
Recalling firm
- Firm
- AvKARE
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 3,817 50-count cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-05-13
- FDA classified
- 2025-06-09
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0460-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.