Medications & Supplements/Prescription Drugs

AvKARE Sunitinib Malate Capsules Recalled for Label Mix-Up

Agency Publication Date: December 4, 2024

Summary

AvKARE has recalled 60 bottles of Sunitinib Malate Capsules (generic sunitinib) due to a label mix-up. The recall involves 40 bottles of the 12.5 mg strength and 20 bottles of the 25 mg strength, both in 28-count bottles. This label error means the dosage strength listed on the outside of the bottle may not match the actual medication inside.

Risk

A label mix-up can cause patients to take the incorrect dose of their medication, potentially leading to ineffective treatment of their condition or an accidental overdose. No injuries or adverse events have been reported to date.

What You Should Do

This recall affects Sunitinib Malate Capsules in 12.5 mg and 25 mg strengths, sold in 28-count bottles and manufactured for AvKARE.
Identify your product by checking the bottle label for the strength (12.5 mg or 25 mg), the NDC number (42291-901-28 or 42291-902-28), and the expiration date of 07/31/2026.
Check the lot number on the bottle: the 12.5 mg strength is affected if it has lot number 100049371, and the 25 mg strength is affected if it has lot number 100049501.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact AvKARE for further instructions.
If you have additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sunitinib Malate Capsules (12.5 mg)

Variants: 12.5 mg, 28-count bottle, Rx Only

Lot Numbers:

100049371 (Exp 07/31/2026)

NDC:

42291-901-28

Quantity: 40 bottles

Product: Sunitinib Malate Capsules (25 mg)

Variants: 25 mg, 28-count bottle, Rx Only

Lot Numbers:

100049501 (Exp 07/31/2026)

NDC:

42291-902-28

Quantity: 20 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95596

Status: Active

Manufacturer: AvKARE

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (40 bottles; 20 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Sunitinib Malate Capsules in 12.5 mg and 25 mg strengths, sold in 28-count bottles and manufactured for AvKARE.

Identify your product by checking the bottle label for the strength (12.5 mg or 25 mg), the NDC number (42291-901-28 or 42291-902-28), and the expiration date of 07/31/2026.

Check the lot number on the bottle: the 12.5 mg strength is affected if it has lot number 100049371, and the 25 mg strength is affected if it has lot number 100049501.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact AvKARE for further instructions.

If you have additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sunitinib Malate Capsules (12.5 mg)

Variants: 12.5 mg, 28-count bottle, Rx Only

Lot Numbers:

100049371 (Exp 07/31/2026)

NDC:

42291-901-28

Quantity: 40 bottles

Product: Sunitinib Malate Capsules (25 mg)

Variants: 25 mg, 28-count bottle, Rx Only

Lot Numbers:

100049501 (Exp 07/31/2026)

NDC:

42291-902-28

Quantity: 20 bottles