Nystatin Bulk Powder Recalled Due to Incorrect Label Strength
Fagron Inc. is recalling 9 containers of Nystatin 2 BU bulk powder because the assay value on the label is incorrect, which could affect dosing accuracy in pharmacy compounding.
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 a pharmaceutical used in prescription compounding where incorrect declared strength could lead to dosing errors. FDA Class II classification indicates the agency considers this significant. Although no illnesses have been reported, the potential for harm from incorrect dosing information justifies this rating.
Plain-English summary
Fagron Inc. is recalling Nystatin 2 BU bulk powder intended for prescription compounding. Nine containers with NDC 51552-0041-4 are affected, specifically lot numbers 230308-U46224 and 221031-U42105, both expiring April 30, 2025.
The recall was initiated due to a label error: the assay value on the label is incorrect. This affects the declared strength of the nystatin in the bulk powder.
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.
The recalled product
- Product
- NYSTATIN 2 BU, 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 51552-0041-4, Bar code 3 51552 00414 6
- Manufacturer
- Fagron, Inc
- Category
- Drug
- Hazard
- labeling-error
- incorrect-strength
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-U46224
- Exp. date 04/30/2025
- 221031-U42105
Distribution
Distribution scope not specified by the agency.
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