Fagron recalls

Fagron appears in 22 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-27.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot K…
  FDA Drug · Class II · 2023-12-27 · Fagron
  Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
• NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot K…
  FDA Drug · Class II · 2023-12-27 · Fagron
  Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
• NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Kno…
  FDA Drug · Class II · 2023-12-27 · Fagron
  Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
• NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob…
  FDA Drug · Class II · 2023-12-27 · Fagron
  Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
• Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Tex…
  FDA Drug · Class III · 2022-05-18 · Fagron
  Reason: Subpotent Drug
• Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN…
  FDA Drug · Class III · 2022-05-18 · Fagron
  Reason: Subpotent Drug
• Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, M…
  FDA Drug · Class III · 2022-05-18 · Fagron
  Reason: Subpotent Drug
• Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texa…
  FDA Drug · Class III · 2022-05-18 · Fagron
  Reason: Subpotent Drug
• Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, M…
  FDA Drug · Class III · 2022-05-18 · Fagron
  Reason: Subpotent Drug
• SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only…
  FDA Drug · Class I · 2022-05-18 · Fagron
  Reason: Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
• LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bit…
  FDA Drug · Class II · 2019-12-11 · Fagron
  Reason: Microbial contamination of non-sterile product.
• SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc
  FDA Drug · Class II · 2018-03-07 · Fagron
  Reason: Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
• Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (ND…
  FDA Drug · Class II · 2017-11-22 · Fagron
  Reason: cGMP Deviations: lack of quality assurance at the API manufacturer.
• Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC…
  FDA Drug · Class II · 2017-05-31 · Fagron
  Reason: cGMP Deviations: lack of quality assurance at the API manufacturer.
• Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (ND…
  FDA Drug · Class II · 2017-05-31 · Fagron
  Reason: cGMP Deviations: lack of quality assurance at the API manufacturer.
• Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5
  FDA Drug · Class III · 2017-05-10 · Fagron
  Reason: 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.
• SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous…
  FDA Drug · Class II · 2016-02-17 · Fagron
  Reason: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
• SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist i…
  FDA Drug · Class II · 2016-02-17 · Fagron
  Reason: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
• SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of o…
  FDA Drug · Class II · 2016-02-17 · Fagron
  Reason: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
• Fagron, Pentravan Base 2.5 Kg, Article number: 802486
  FDA Drug · Class II · 2014-08-06 · Fagron
  Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
• Fagron, Phytobase Cream, 500 g, Article number: 802156
  FDA Drug · Class II · 2014-08-06 · Fagron
  Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
• Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749
  FDA Drug · Class II · 2014-08-06 · Fagron
  Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.