DrugDec 27, 2023
Fagron NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container recall — FDA D-0154-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class IIFDA: OngoingFagron, Inc.
Recall history in this database
Classification mix: Class II: 15, Class III: 1, Class I: 1.
DrugDec 27, 2023
Fagron NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container recall — FDA D-0155-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class IIFDA: OngoingFagron, Inc.
DrugDec 27, 2023
Fagron NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container recall — FDA D-0156-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class IIFDA: OngoingFagron, Inc.
DrugDec 27, 2023
Fagron NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container recall — FDA D-0157-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class IIFDA: OngoingFagron, Inc.
DrugMay 18, 2022
Fagron SyrSpend SF Suspending Base, Cherry Flavored recall — FDA D-0856-2022
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class IFDA: CompletedFagron, Inc.
DrugDec 11, 2019
Fagron LETS GEL KIT Convenience Pack recall — FDA D-0533-2020
Microbial contamination of non-sterile product.
Class IIFDA: TerminatedFagron, Inc.
DrugMar 7, 2018
Fagron SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L recall — FDA D-0547-2018
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Class IIFDA: TerminatedFagron, Inc.
DrugNov 22, 2017
Fagron Estriol, For Prescription Compounding recall — FDA D-0079-2018
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class IIFDA: TerminatedFagron, Inc.
DrugMay 31, 2017
Fagron Estrone, For Prescription Compounding recall — FDA D-0792-2017
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class IIFDA: TerminatedFagron, Inc.
DrugMay 31, 2017
Fagron Estriol, For Prescription Compounding recall — FDA D-0791-2017
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class IIFDA: TerminatedFagron, Inc.
DrugMay 10, 2017
Fagron Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob recall — FDA D-0695-2017
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Class IIIFDA: TerminatedFagron, Inc.
DrugFeb 17, 2016
Fagron SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially recall — FDA D-0654-2016
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class IIFDA: TerminatedFagron, Inc.
DrugFeb 17, 2016
Fagron SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending recall — FDA D-0656-2016
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class IIFDA: TerminatedFagron, Inc.
DrugFeb 17, 2016
Fagron SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free recall — FDA D-0655-2016
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class IIFDA: TerminatedFagron, Inc.
DrugAug 6, 2014
Fagron recall — FDA D-1496-2014
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class IIFDA: TerminatedFagron, Inc.
DrugAug 6, 2014
Fagron recall — FDA D-1498-2014
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class IIFDA: TerminatedFagron, Inc.
DrugAug 6, 2014
Fagron recall — FDA D-1497-2014
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class IIFDA: TerminatedFagron, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Fagron, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.