D-0292-2026 Class II Ongoing
FDA drug recall D-0292-2026 was initiated by AvKARE on December 31, 2025 and is designated Class II. Reason for recall: Out of specification for dissolution. The recall status is ongoing. Affected quantity: 7,991 5x10 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- January 14, 2026
- Initiation Date
- December 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,991 5x10 cartons
Product Description
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
Reason for Recall
Out of specification for dissolution.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #49124, Exp Date 12/31/2026