FDAFDA · Food and drugs·Recall number D-0104-2025
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Published December 11, 2024 · Recall initiated: October 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-Up
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SUNITINIB MALATE
- Manufacturer
- AvKARE
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 100049501, Exp. Date 07/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.