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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Voriconazole Oral Suspension Recalled for Missing Package Insert

Agency Publication Date: February 16, 2024
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Summary

Lupin Pharmaceuticals Inc. is recalling three lots of Voriconazole for Oral Suspension (40mg/mL), an orange-flavored antifungal medication. The recall was initiated because the products may have incorrect or missing package inserts. These inserts contain critical information regarding proper dosage, preparation instructions, and safety warnings necessary for the effective use of the medication.

Risk

A missing or incorrect package insert can lead to improper mixing or incorrect dosing of the medication. This could result in a patient receiving too much or too little of the drug, potentially leading to treatment failure or an increased risk of adverse side effects.

What You Should Do

  1. This recall affects orange-flavored Voriconazole for Oral Suspension (40mg/mL) packaged in 49g/75mL bottles with NDC 43386-038-60.
  2. Check your medication bottle for lot numbers S200756 (Exp. 10/2024), S300218 (Exp. 04/2025), or S300633 (Exp. 09/2025).
  3. 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 Lupin Pharmaceuticals Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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.
๐Ÿ—‘๏ธ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 for Oral Suspension (40mg/mL)
Variants: Orange-Flavored, 40mg/mL, 49g/75mL when reconstituted
Lot Numbers:
S200756 (Exp. 10/2024)
S300218 (Exp. 04/2025)
S300633 (Exp. 09/2025)
NDC:
43386-038-60

Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 for Lupin Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93934
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Retail Pharmacies
Manufactured In: United States
Distributed To: Ohio, Illinois, New Jersey

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 ยท 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.