Recalls / Class II
Class IID-0292-2026
Product
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
- Brand name
- Rosuvastatin
- Generic name
- Rosuvastatin
- Active ingredient
- Rosuvastatin Calcium
- Route
- Oral
- NDCs
- 50268-709, 50268-710, 50268-711
- FDA application
- ANDA207616
- Affected lot / code info
- Lot #49124, Exp Date 12/31/2026
Why it was recalled
Out of specification for dissolution.
Recalling firm
- Firm
- AvKARE
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 7,991 5x10 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-31
- FDA classified
- 2026-01-20
- Posted by FDA
- 2026-01-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0292-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.