Voriconazole for Oral Suspension — Class II drug recall D-0337-2024
Terminated recall by Lupin Pharmaceuticals Inc., reported 2024-02-28, distributed in IL, NJ, OH. Labeling: Incorrect or Missing Package Insert
| Recall number | D-0337-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2024-02-05 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Terminated | 2024-12-27 |
| Distributed | IL, NJ, OH |
| Reason classes | labeling |
| NDC | 43386-0038, 43386-0038-60 |
| Lot numbers | S200756, S300218, S300633 |
| Expiration dates | 2024-10, 2025-04, 2025-09 |
Product
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.
Reason for recall
Labeling: Incorrect or Missing Package Insert
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0337-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.