Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NYSTATIN 2 BU Recalled by Fagron, Inc Due to Labeling: Label Error on Declared Strength: Assay value...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fagron, Inc directly.
Affected Products
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
Quantity: 9 containers
Why Was This Recalled?
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Where Was This Sold?
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.
About Fagron, Inc
Fagron, Inc has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report