Rosuvastatin Tablets, USP, 10 mg, Rx Only
Recalled by AvKARE
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
AvKARE has recalled Rosuvastatin Tablets, USP, 10 mg, Rx Only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on January 14, 2026 and was initiated on December 31, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Rosuvastatin Tablets, USP, 10 mg, Rx Only, with approximately 7,991 5x10 cartons affected. The company behind the recall is AvKARE, based in Pulaski, TN. The FDA describes the product as: “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”
Why was Rosuvastatin Tablets, USP, 10 mg, Rx Only recalled?
According to the FDA, the stated reason for the recall is: “Out of specification for dissolution.” In plain terms, this recall relates to a potency or effectiveness issue.
This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.
What should you do?
If you think you may have bought Rosuvastatin Tablets, USP, 10 mg, Rx Only, compare it against the product description and identifying codes (Lot #49124, Exp Date 12/31/2026) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact AvKARE or your local health authority.
About this recall
This recall was distributed in TN. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- January 14, 2026
- Recall started
- December 31, 2025
- Distributed in
- TN
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Rosuvastatin Tablets, USP, 10 mg, Rx Only recalled?+
According to the FDA: Out of specification for dissolution.
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Rosuvastatin Tablets, USP, 10 mg, Rx Only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0292-2026. Information last synced from the FDA on July 5, 2026.