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Class II · ModerateActive recall

Rosuvastatin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #49124, Exp Date 12/31/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Out of specification for dissolution.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAvPAK
Brand nameROSUVASTATIN
Generic nameROSUVASTATIN
Active ingredient(s)ROSUVASTATIN CALCIUM
Distributed by / forAvKARE, Pulaski, TN 38478
NDC50268-709-15
Show the full FDA record
Full product labelRosuvastatin 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
Recalling firmAvKARE
DistributionNationwide in the USA
Quantity7,991 5x10 cartons
Recall initiated2025-12-31
Report date2026-01-14
Recall completed—
Recall numberD-0292-2026
ClassificationClass II
FDA statusOngoing
Origin on filePulaski TN United States

Related

Rosuvastatin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.