CLASS II ONGOING Drug recall · Reported 11 Dec 2024 · FDA Enforcement Report
Sunitinib Malate Capsules, 5 mg recalled by AvKARE
AvKARE is recalling Sunitinib Malate Capsules, 5 mg, distributed nationwide in the US. The recall was initiated on 18 Oct 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0103-2025
- FDA event ID
- 95596
- Recalling firm
- AvKARE, Pulaski, TN
- Brand
- Sunitinib Malate
- Manufacturer
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Oct 2024
- FDA classified
- 4 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 18 Oct 2024 | Recall initiated by company | |
| 4 Dec 2024 | Classified by FDA | +47 days |
| 11 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Sunitinib Malate Capsules, 5 mg recalled?
Yes. AvKARE recalled Sunitinib Malate Capsules, 5 mg on 18 Oct 2024. The recall is Class II and its status is Ongoing. Recall number D-0103-2025.
Why was it recalled?
Labeling: Label Mix-Up
Which lots are affected?
Lot #: 100049371, Exp. Date 07/31/2026
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Sunitinib Malate recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sunitinib Malate Capsules, 25 mg recalled by AvKARESunitinib Malate | AvKARE | Packaging Defects | Nationwide |
| Drug | CLASS II | Sunitinib Malate Capsules, 5 mg recalled by Teva Pharmaceuticals USASunitinib Malate | Teva Pharmaceuticals USA | Other | Nationwide |