Sunitinib Malate Capsules recall
FDA recall D-0103-2025 · initiated Oct 18, 2024
AvKARE recalled Sunitinib Malate Capsules in Oct 2024 — an FDA Class II recall (D-0103-2025) because Labeling: Label Mix-Up.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Label Mix-Up
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 40 bottles
Details
- Product
- Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
- Recalling company
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Oct 18, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was Sunitinib Malate Capsules recalled?
- AvKARE recalled Sunitinib Malate Capsules in Oct 2024 — an FDA Class II recall (D-0103-2025) because Labeling: Label Mix-Up. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sunitinib Malate Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0103-2025 was: Labeling: Label Mix-Up
- Is a recalled Sunitinib Malate Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sunitinib Malate Capsules are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 100049371, Exp. Date 07/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0103-2025.