---
title: "NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only... — FDA record D-0154-2024 | Is It on Recall"
description: "Labeling: Label Error on Declared Strength: Assay value on the label is incorrect."
url: https://isitonrecall.com/recall/fda-drug-d-0154-2024-nystatin-5bu-activity-as-is-6482-units-mg-bulk-powder-container-rx-only-for-prescription-compounding/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0154-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0154-2024%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Nystatin records](https://isitonrecall.com/drug/nystatin/) [Medications records](https://isitonrecall.com/category/medications/) [Fagron, Inc records](https://isitonrecall.com/brand/fagron-inc/)