December 2025 FDA Recall Rosuvastatin by Avkare
D-0292-2026 - Out of specification for dissolution.
This Class II drug recall was voluntarily initiated by Avkare on December 31, 2025 for the product Rosuvastatin. The FDA reported the reason for recall as out of specification for dissolution.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0292-2026
Out of specification for dissolution.
12-31-2025
01-14-2026
7,991 5x10 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AvKARE
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 49124, Exp Date 12/31/2026
