Medications & Supplements/Prescription Drugs

Teva Sunitinib Malate Capsules Recalled for High Moisture Content

Agency Publication Date: July 7, 2023

Summary

Teva Pharmaceuticals USA Inc. has recalled approximately 180 bottles of Sunitinib Malate Capsules (12.5 mg), a medication used to treat certain types of cancer. The recall was initiated because testing showed water (moisture) content above the approved specifications for the product. No injuries or medical issues have been reported in connection with this recall.

Risk

Excessive moisture in the medication can cause the active ingredients to degrade or lose stability. This could potentially reduce the effectiveness of the drug for patients relying on it for cancer treatment.

What You Should Do

This recall affects 28-count bottles of Sunitinib Malate Capsules, 12.5 mg, manufactured by Teva Pharmaceuticals USA, Inc. with NDC 0093-8199-28.
Check your medication bottle for lot number 100037220 with an expiration date of 10/2024.
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 Teva Pharmaceuticals USA Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report a concern.

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 bottles

Lot Numbers:

100037220 (Exp 10/2024)

NDC:

0093-8199-28

Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; Recall #: D-0913-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92636

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA Inc

Sold By: wholesalers; distributors

Manufactured In: United States

Units Affected: 180 bottles

Distributed To: Nationwide

Agency Last Updated: July 11, 2023

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 28-count bottles of Sunitinib Malate Capsules, 12.5 mg, manufactured by Teva Pharmaceuticals USA, Inc. with NDC 0093-8199-28.

Check your medication bottle for lot number 100037220 with an expiration date of 10/2024.

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 Teva Pharmaceuticals USA Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report a concern.