# FDA recall D-0155-2024

> **Fagron, Inc** · Class II · drug recall initiated 2023-12-11.

## Product

NYSTATIN 500 MU, 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 51552-0041-3, Bar code 3 51552 00413 9

## Reason for recall

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

## 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.

## Key facts

- **Recall number:** D-0155-2024
- **Recalling firm:** Fagron, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-12-11
- **Report date:** 2023-12-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2024

## Citation

> AI Analytics. FDA recall D-0155-2024. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0155-2024. Source: US FDA. Licensed CC0.

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