Nystatin bulk powder recall due to incorrect assay strength label
Fagron, Inc. is recalling Nystatin 5BU bulk powder for prescription compounding due to an incorrect assay strength label. The product was distributed to pharmacies and repacker/relabelers in the United States and Canada.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves incorrect pharmaceutical potency labeling on a compounding ingredient, which creates a risk of harm through incorrect dosing in compounded medications. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product without reported injury, corresponding to High severity.
Plain-English summary
Fagron, Inc. is recalling 13 containers of Nystatin 5BU (Activity: 6482 Units/mg) bulk powder for prescription compounding. The recall is due to an incorrect assay value listed on the product label.
The recalled product (Lot 230308-U46196, expiration date 04/30/2025, NDC 51552-0041-5) was distributed to one distributor, which may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada for use in prescription compounding.
Healthcare professionals and compounding pharmacies who have received this product should verify the actual assay value with Fagron, Inc. before using the product for compounding. Patients who have received medications compounded using this ingredient should consult with their healthcare provider or pharmacist if they have concerns.
The recalled product
- 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
- Manufacturer
- Fagron, Inc
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 230308-U46196
- Exp. date 04/30/2025
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Fagron, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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