FDA recall D-0292-2026

AvKARE · Class II · drug

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

Reason for recall

Out of specification for dissolution.

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-12-31
Report date: 2026-01-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2026