CLASS II Drug recall · Reported 28 Feb 2024 · FDA Enforcement Report
Voriconazole for Oral Suspension, 40mg/mL recalled
Lupin Pharmaceuticals is recalling Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored when reconstituted, distributed in Illinois, New Jersey, Ohio. The recall was initiated on 5 Feb 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0337-2024
- FDA event ID
- 93934
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Voriconazole
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Feb 2024
- FDA classified
- 16 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
Timeline
| 5 Feb 2024 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +11 days |
| 28 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Package Insert
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.
Where it was distributed
OH, IL, NJ
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Package Insert
Which lots are affected?
Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
Where was it sold?
OH, IL, NJ
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Voriconazole recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Voriconazole Tablets 200 mg recalled by Glenmark PharmaceuticalsVoriconazole | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Voriconazole Tablets 50mg recalled by Glenmark PharmaceuticalsVoriconazole | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Voriconazole Tablets, 50 mg recalled by Amerisource Health ServicesVoriconazole | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Voriconazole 10mg/ML Dropper) Oph Solution recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS III | Voriconazole Tablets, 200 mg cartons Dose recalled by AVKARE | Avkare | Potency & Assay | Nationwide |