FDA recall, , Moderate risk
AvKARE Rosuvastatin Tablets
Rosuvastatin Tablets, USP, 10 mg, are out of specification for dissolution.
Summary by Recall Canary from the FDA notice
What happened
AvKARE, of Pulaski, Tennessee, recalled Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, because the product was out of specification for dissolution. The FDA added the recall to its Enforcement Report on January 7, 2026, and classified it on January 20, 2026. The company began the recall on December 31, 2025, and the product was distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Rosuvastatin Tablets, USP, 10 mg
- NDC
- 50268-709-15
- Lot code
- 49124
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- AvKAREPulaski, Tennessee
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98246
- Recall number
- D-0292-2026
- Quantity recalled
- 7,991 5x10 cartons
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Listed on Recall Canary
