FDA-Drug2026-01-14Class IIPROCESSING DEFECT
AvKARE Rosuvastatin 10 mg tablets recalled for dissolution defect
What this means
AvKARE is recalling Rosuvastatin 10 mg tablets (Lot #49124, expiring 12/31/2026) because they don't dissolve properly in the body. This means the medication may not work as intended. No injuries have been reported so far.
- Check if you have this medication: NDC 50268-709-15, Lot #49124, expiration date 12/31/2026
- Stop taking the affected tablets
- Contact your pharmacy or doctor for a replacement prescription
- Do not flush or throw away the medication; ask your pharmacy how to safely return or dispose of it
The agency's original wording
Hazard
Out of specification for dissolution.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
7,991 5x10 cartons
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.