Recall archive / FDA drug enforcement

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the b... — FDA record D-0337-2024

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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: Labeling: Incorrect or Missing Package Insert
Classification: Class II
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: N/A
Agency-reported status: Terminated
Source record identifier: D-0337-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

OH, IL, NJ

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 28, 2024
Recall initiation date: Feb 5, 2024
Center classification date: Feb 16, 2024
Termination date: Dec 27, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.