Nystatin Powder Recall Due to Incorrect Assay Strength on Label
Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.
What this means for you
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 is an FDA Class II recall of a drug product with an incorrect labeled strength. No illnesses or injuries have been reported. The hazard—incorrect potency information during compounding—is theoretical but significant for medication dosing.
Plain-English summary
Fagron, Inc. is recalling 46 containers of NYSTATIN 500 MU bulk powder with assay value of 6482 Units/mg, which is used for prescription compounding. The product carries NDC number 51552-0041-3 and includes two lot numbers: 230308-U46225 (expiration 04/30/2025) and 221031-U42110 (expiration 04/30/2025).
The recall was initiated because the assay value declared on the product label is incorrect. An accurate assay value is critical for compounders who rely on the labeled strength to prepare patient medications with the correct potency. An incorrect labeled strength could result in doses that do not match the prescriber's intent.
The product was distributed to one distributor, which may have further distributed it to repacker/relabelers and pharmacies in the United States and Canada for prescription compounding purposes. Consumers and healthcare providers who have this product should stop using it and consult with their pharmacy or physician about obtaining product from an alternative source.
The FDA has classified this as a Class II recall.
The recalled product
- 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
- Manufacturer
- Fagron, Inc
- Hazard
- labeling-error
- strength-mislabeling
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 (3)
- Lot #: 230308-U46225
- Exp. date 04/30/2025
- 221031-U42110
Distribution
Distribution scope not specified by the agency.
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