Voriconazole for Oral Suspension recall
FDA recall D-0337-2024 · initiated Feb 5, 2024
Lupin Pharmaceuticals Inc. recalled Voriconazole for Oral Suspension in Feb 2024 — an FDA Class II recall (D-0337-2024) because Labeling: Incorrect or Missing Package Insert.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Incorrect or Missing Package Insert
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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.
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- OH, IL, NJ
- Initiated
- Feb 5, 2024
- FDA report date
- Feb 28, 2024
Frequently asked
- Was Voriconazole for Oral Suspension recalled?
- Lupin Pharmaceuticals Inc. recalled Voriconazole for Oral Suspension in Feb 2024 — an FDA Class II recall (D-0337-2024) because Labeling: Incorrect or Missing Package Insert. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Voriconazole for Oral Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0337-2024 was: Labeling: Incorrect or Missing Package Insert
- Is a recalled Voriconazole for Oral Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Voriconazole for Oral Suspension are affected?
- Distributed: OH, IL, NJ. The recall covers these lots — Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0337-2024.