Recall archive / FDA drug enforcement
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, ... — FDA record D-0154-2024
Reported ongoing
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 Dec 11, 2023. 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
- NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
- Reason
- Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
- Classification
- Class II
- Recalling firm
- Fagron, Inc
- Quantity
- 13 containers
- Agency-reported status
- Ongoing
- Source record identifier
- D-0154-2024
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#: 230308-U46196, Exp. date 04/30/2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Dec 11, 2023
- Center classification date
- Dec 21, 2023
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.