openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 4
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
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Label Error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Code information
Lot#: 230308-U46196, Exp. date 04/30/2025
Distribution pattern
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.
drug · product 2 of 4
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
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Label Error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Code information
Lot #: 230308-U46225, Exp. date 04/30/2025, 221031-U42110, Exp. date 04/30/2025
Distribution pattern
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.
drug · product 3 of 4
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
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Label Error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Code information
Lot #: 230308-U46224, Exp. date 04/30/2025, 221031-U42105, Exp. date 04/30/2025
Distribution pattern
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.
drug · product 4 of 4
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
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Label Error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Code information
Lot #: 221031-U42104, Exp. date 04/30/2025
Distribution pattern
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.
