Skip to content
Get alerts
GovInfoNow
Lower risk Drug recall · FDA · Published February 5, 2024

Lupin Voriconazole Oral Suspension Recall: Missing Package Insert Hazard

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0337-2024DrugLupin Pharmaceuticals ›
Take action

Contact the company

Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/32837-lupin-voriconazole-oral-suspension-recall-missing-package-insert-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/32837-lupin-voriconazole-oral-suspension-recall-missing-package-insert-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #D-0337-2024

Cite this page

“Lupin Voriconazole Oral Suspension Recall: Missing Package Insert Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32837-lupin-voriconazole-oral-suspension-recall-missing-package-insert-hazard. Based on FDA recall #D-0337-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0337-2024%22&limit=1).

The FDA announced on Feb. 5, 2024, that Lupin Pharmaceuticals Inc. is recalling Voriconazole for Oral Suspension due to incorrect or missing package inserts. The agency issued recall number D-0337-2024 for the voluntary Class II action.

How to tell if you have it

  • Brand: Lupin Pharmaceuticals
  • Product: Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted
  • NDC: 43386-038-60
  • Lot S200756; Exp. 10/2024
  • Lot S300218; Exp. 04/2025
  • Lot S300633; Exp. 09/2025
  • Sold in OH, IL, NJ

The hazard

The recall addresses labeling issues involving incorrect or missing package inserts for the drug. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since Jan. 31, 2013. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (Aug. 3, 2026), Lupin Glucagon Emergency Kit Recall (June 23, 2026), and Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026). Other recent recalls of similar products include American Regent Levocarnitine Injection Recall (April 16, 2026), Ajanta Pharma Aripiprazole Tablets 30mg (May 27, 2026), and Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (Dec. 30, 2025).

How to tell if you have this one

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.

  • Brand
    Lupin Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Package Insert

    Ensure the package insert is present and correct before using the medication.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “OH, IL, NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, New Jersey, Ohio.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Feb 5, 202412. FDA classified it Class II: Feb 16, 202423. Published in FDA’s Enforcement Report: Feb 28, 202434. FDA terminated the recall: Dec 27, 202442024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

American Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health PackagingTeva Recalls Metoclopramide Tablets Due to Foreign Contaminants
Teva Pharmaceuticals USA, IncPreferred Pharma Recalls Lidocaine Ointment Due to Content Issues
Preferred Pharmaceuticals, Inc.Northstar Rx Recalls Tretinoin Cream Due to Impurities
SUN PHARMACEUTICAL INDUSTRIES INCApothecary Pharma Recalls Tirzepatide Injections Due to Sterility Risk
Apothecary Pharma LLC

Other Lupin Pharmaceuticals recalls

Lupin Pharmaceuticals Inc. recalls Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL
August 3, 2026Lupin Pharmaceuticals Inc. recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL
June 23, 2026Lupin Pharmaceuticals Inc. recalls prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC
June 4, 2026Lupin Pharmaceuticals Inc. recalls Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108,
April 24, 2026Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only,
November 13, 2025Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals,
November 5, 2025

Keep exploring

Where this comes from

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.

  • Official source: FDA Recall #D-0337-2024 (February 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0337-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA