Lupin Pharmaceuticals recalls Voriconazole oral suspension (40mg/mL, orange-flavored) due to missing package insert. This may affect safe use of the medication. Check product details and contact Lupin for instructions.
Labeling: Incorrect or Missing Package Insert
Lupin Pharmaceuticals is recalling Voriconazole oral suspension (40mg/mL, orange-flavored) because the package insert may be missing or incorrect. This could lead to improper use of the medication if the instructions are not followed correctly.
The package insert may be missing or incorrect, which could lead to improper use of the medication. Without clear instructions, users might not follow the correct mixing and dosage procedures, potentially causing ineffective treatment or adverse effects.
People using Voriconazole oral suspension for fungal infections who received this specific product. Those with the orange-flavored, 40mg/mL concentration are most at risk.
Check for the product name 'Voriconazole for Oral Suspension', 40mg/mL, orange-flavored, 49g/75mL when reconstituted. The lot numbers S200756 (exp. 10/2024), S300218 (exp. 04/2025), and S300633 (exp. 09/2025) are associated with this recall.
Ensure the package insert is present and correct before using the medication.
The recall is due to a potential missing or incorrect package insert, which could affect proper use. If the insert is missing, contact Lupin Pharmaceuticals for guidance.
Check the product details and lot numbers to see if it's affected. If it is, contact Lupin Pharmaceuticals for instructions on how to handle it.
Look for the product name 'Voriconazole for Oral Suspension', 40mg/mL, orange-flavored, 49g/75mL when reconstituted. Check the lot numbers S200756 (exp. 10/2024), S300218 (exp. 04/2025), or S300633 (exp. 09/2025).
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0337-2024 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0337-2024 from Lupin Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.