Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sunitinib Malate Capsules Recalled by AvKARE Due to Labeling: Label Mix-Up

Date: October 18, 2024
Company: AvKARE
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AvKARE directly.

Affected Products

Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28

Quantity: 20 bottles

Why Was This Recalled?

Labeling: Label Mix-Up

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AvKARE

AvKARE has 20 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report