Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Sunitinib Malate Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mix-Up
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Affected NDC
42291-0901-28
Compare with the code on your package — it is the most precise check available.
Drug: Sunitinib
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sunitinib Malate NDC 42291-0901 |
12.5 mg/1 | Capsule Oral |
AvKARE | Rx |
- Recalling firm
- AvKARE
- NDC code
- 42291-901-28
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0103-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Sunitinib recalls
See all
Class II · Moderate risk
Sunitinib Malate Capsules
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
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