Medications & Supplements/Prescription Drugs

American Health Packaging Febuxostat Tablets Recalled for Manufacturing Issues

Agency Publication Date: February 6, 2024

Summary

Amerisource Health Services LLC is recalling 1,932 cartons of Febuxostat tablets (40 mg) sold under the American Health Packaging brand. The recall was initiated because of deviations from Current Good Manufacturing Practice (CGMP) requirements, which are the federal standards for drug quality and consistency. If you use this medication, you should consult with your healthcare provider or pharmacist for advice regarding your treatment.

Risk

Failure to follow proper manufacturing standards can affect the quality, purity, or potency of the medication. While no specific injuries or adverse health effects have been reported, using medication that does not meet quality standards could lead to ineffective treatment.

What You Should Do

This recall involves American Health Packaging Febuxostat tablets (40 mg), which are prescription medications packaged in cartons containing 30 tablets (arranged in three unit-dose strips of 10).
To determine if your medication is affected, check the outer carton for NDC 60687-538-21 and lot number 1015033 (Expiration: 06/30/2025) or 1016409 (Expiration: 08/31/2025). The individual unit-dose strips will display NDC 60687-538-11.
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 Amerisource Health Services LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding consumer safety.

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: Febuxostat Tablets (40 mg)by American Health Packaging

Variants: 40 mg, 30 Tablets (3 x 10) per carton, Rx only

Lot Numbers:

1015033 (exp. 06/30/2025)

1016409 (exp. 08/31/2025)

NDC:

60687-538-21

60687-538-11

Distributed by American Health Packaging, Columbus, Ohio.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93918

Status: Resolved

Manufacturer: Amerisource Health Services LLC

Sold By: Pharmacies; Hospitals; Healthcare providers

Manufactured In: United States

Units Affected: 1,932 cartons

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 involves American Health Packaging Febuxostat tablets (40 mg), which are prescription medications packaged in cartons containing 30 tablets (arranged in three unit-dose strips of 10).

To determine if your medication is affected, check the outer carton for NDC 60687-538-21 and lot number 1015033 (Expiration: 06/30/2025) or 1016409 (Expiration: 08/31/2025). The individual unit-dose strips will display NDC 60687-538-11.

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 Amerisource Health Services LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding consumer safety.