Drug FDA Class II Ongoing Failed specifications

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

AvKARE Published Jan 14, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact AvKARE or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Out of specification for dissolution.

Hazards

Failed Dissolution · primary

Affected products (1)

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

ROSUVASTATIN · 7,991 5x10 cartons

NDC: 50268-709, 50268-710, 50268-711, 50268-709-11, 50268-709-15, 50268-710-11, 50268-710-15, 50268-711-11, 50268-711-15

Lot codes: 49124

Code info: Lot #49124, Exp Date 12/31/2026

Affected areas

Nationwide

Timeline

Initiated

Dec 31, 2025
Published

Jan 14, 2026

Recall number: D-0292-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.