Rosuvastatin tablets recalled after failing a dissolution specification
AvKARE is recalling 7,991 cartons of Rosuvastatin Tablets, USP 10 mg, because the product was out of specification for dissolution.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an out of specification dissolution result with no stated clinical consequence or reported harm.
Plain-English summary
Rosuvastatin Tablets, USP, 10 mg, supplied as 50 tablets (5 x 10) unit dose per carton, manufactured for AvKARE of Pulaski, Tennessee, under NDC 50268-709-15, are being recalled.
The reason given in the enforcement record is that the product was out of specification for dissolution.
The recall covers 7,991 5x10 cartons from lot 49124, expiry 12/31/2026. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record describes a specification failure rather than a reported patient harm. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific carton is affected and arrange a replacement.
The recalled product
- Product
- ROSUVASTATIN (ROSUVASTATIN)
- Brand
- ROSUVASTATIN
- Manufacturer
- AvKARE
- Category
- Drug — Statin
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #49124
- Exp Date 12/31/2026
Distribution
Distributed nationwide across the United States.
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