Recall: D-0104-2025

Class II - Potentially Harmful

Class IIClassification

2024-10-18Initiated

OngoingStatus

AvKAREFirm

Product

Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28

Reason

Labeling: Label Mix-Up

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.