Sunitinib Malate recalls

The FDA has published 3 recalls involving Sunitinib Malate since 2023. The latest was reported on 11 Dec 2024. Most were for packaging defects. AvKARE has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2023

Last 12 months0reported

Class I00% of total

Ongoing2latest 11 Dec 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 2 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why sunitinib malate is recalled

Packaging Defects267%
Other Reasons133%

Companies

AvKARE267%
Teva Pharmaceuticals USA133%

By year

2024267%
2023133%

Ongoing sunitinib malate recalls

2 active

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024Drug	CLASS II	Sunitinib Malate Capsules, 25 mg recalled by AvKARESunitinib Malate	AvKARE	Packaging Defects	Nationwide
11 Dec 2024Drug	CLASS II	Sunitinib Malate Capsules, 5 mg recalled by AvKARESunitinib Malate	AvKARE	Packaging Defects	Nationwide

All sunitinib malate recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024Drug	CLASS II	Sunitinib Malate Capsules, 25 mg recalled by AvKARESunitinib Malate	AvKARE	Packaging Defects	Nationwide
11 Dec 2024Drug	CLASS II	Sunitinib Malate Capsules, 5 mg recalled by AvKARESunitinib Malate	AvKARE	Packaging Defects	Nationwide
19 Jul 2023Drug	CLASS II	Sunitinib Malate Capsules, 5 mg recalled by Teva Pharmaceuticals USASunitinib Malate	Teva Pharmaceuticals USA	Other	Nationwide

Should you stop taking Sunitinib Malate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.