Nystatin Bulk Powder Recall for Incorrect Label Assay Value
Fagron, Inc. is recalling Nystatin 150 MU bulk powder for prescription compounding because the assay value on the label is incorrect.
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: Although this is an FDA Class II labeling error with no reported illnesses or injuries, an incorrect assay value on a pharmaceutical compounding ingredient poses a potential risk of harm through dosing errors. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Fagron, Inc. is recalling Nystatin 150 MU bulk powder due to a labeling error. The assay value declared on the label is incorrect. The U.S. Food and Drug Administration has classified this as a Class II recall.
The affected product consists of 52 containers with NDC 51552-0041-1, lot number 221031-U42104, and expiration date 04/30/2025. This is a bulk powder intended for use in prescription compounding.
The product was distributed to one pharmaceutical distributor, which may have further distributed it to repacker/relabelers and compounding pharmacies throughout the United States and Canada.
The recalled product
- Product
- NYSTATIN 150 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 51552-0041-1, Bar code 3 51552 00411 5
- Manufacturer
- Fagron, Inc
- Affected units
- 52
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 #: 221031-U42104
- 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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