Why it was recalled
Labeling: Label Mix-Up
Product description
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Lot numbers, UPCs & expiration codes
Lot #: 100049371, Exp. Date 07/31/2026
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0103-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 18, 2024
- FDA report date
- Dec 11, 2024
- Quantity
- 40 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0103-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 95596
- Address
- 615 N 1st St
- Code information
- Lot #: 100049371, Exp. Date 07/31/2026
- Postal code
- 38478-2403
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0103-2025
- Classification
- Class II
- Recalling firm
- AvKARE
- Product quantity
- 40 bottles
- Reason for recall
- Labeling: Label Mix-Up
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 4, 2024