FDA Drugs recall ·
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only… recall
Read the official FDA notice ↗
Product
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Why was it recalled?
Labeling: Label Mix-Up
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 100049501, Exp. Date 07/31/2026
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0104-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.