Recall archive / FDA drug enforcement
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vado... — FDA record D-0595-2024
Reported completed
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 Jul 2, 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
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
- Reason
- Cross contamination with other products
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Quantity
- 12720 vials
- Agency-reported status
- Completed
- Source record identifier
- D-0595-2024
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 #: L300220, Exp. 05/31/2025. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the USA and Puerto Rico
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 17, 2024
- Recall initiation date
- Jul 2, 2024
- Center classification date
- Jul 10, 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.