Medications & Supplements/Prescription Drugs

American Health Packaging Voriconazole Tablets Recalled for Quality Issues

Agency Publication Date: March 31, 2025

Summary

Amerisource Health Services LLC is recalling 889 cartons of Voriconazole (50 mg) tablets, which were distributed by American Health Packaging. This prescription antifungal medication is being recalled due to manufacturing quality issues (cGMP deviations) that occurred when a supplier repackaged the product. The affected medication is packaged in cartons containing three blister cards, providing a total of 30 individual doses per carton.

Risk

Failure to follow current Good Manufacturing Practices (cGMP) during the repackaging process can compromise the quality and integrity of the medication. While no specific health incidents have been reported, using medication that does not meet manufacturing standards may pose a risk to patient safety.

What You Should Do

This recall affects Voriconazole (50 mg) tablets sold in cartons of 30 individual blistered doses (3 blister cards per carton) under the American Health Packaging brand.
Identify affected products by looking for Carton NDC 60687-294-21 and Unit Dose NDC 60687-294-11 on the packaging.
Check the lot number on the carton or blister card for lot number 1014138 with an expiration date of 04/30/2025.
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 the manufacturer 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 this recall.

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: Voriconazole Tablets (50 mg)by American Health Packaging

Variants: 50 mg, 30 Unit Dose per carton, 3 blister cards

Lot Numbers:

1014138 (Exp 04/30/2025)

NDC:

60687-294-21

60687-294-11

Rx only medication distributed by American Health Packaging.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96574

Status: Resolved

Manufacturer: Amerisource Health Services LLC

Sold By: American Health Packaging

Manufactured In: United States

Units Affected: 889 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

Risk

What You Should Do

This recall affects Voriconazole (50 mg) tablets sold in cartons of 30 individual blistered doses (3 blister cards per carton) under the American Health Packaging brand.

Identify affected products by looking for Carton NDC 60687-294-21 and Unit Dose NDC 60687-294-11 on the packaging.

Check the lot number on the carton or blister card for lot number 1014138 with an expiration date of 04/30/2025.

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 the manufacturer 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 this recall.