Qualgen Recalls
27 recalls on record · December 2, 2015 to July 23, 2025 · Drugs
Recalls by year
15
17
18
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 23, 2025DrugsFDA
Qualgen, LLC recalls Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edm
Hazard: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
November 14, 2018DrugsFDA
Qualgen, LLC recalls Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 6976
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 co
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edm
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 c
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 c
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 cou
Hazard: Lack of Assurance of Sterility
November 14, 2018DrugsFDA
Qualgen, LLC recalls Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count
Hazard: Lack of Assurance of Sterility
July 11, 2018DrugsFDA
Qualgen, LLC recalls TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 7
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date.
July 11, 2018DrugsFDA
Qualgen, LLC recalls ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013.
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date.
June 14, 2017DrugsFDA
Qualgen recalls Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Offic
Hazard: CGMP deviations- Lack of Quality Assurance
June 14, 2017DrugsFDA
Qualgen recalls Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Offi
Hazard: CGMP deviations- Lack of Quality Assurance
June 14, 2017DrugsFDA
Qualgen recalls Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Of
Hazard: CGMP deviations- Lack of Quality Assurance
June 14, 2017DrugsFDA
Qualgen recalls Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Offi
Hazard: CGMP deviations- Lack of Quality Assurance
June 14, 2017DrugsFDA
Qualgen recalls Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile O
Hazard: CGMP deviations- Lack of Quality Assurance
June 14, 2017DrugsFDA
Qualgen recalls Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only
Hazard: CGMP deviations- Lack of Quality Assurance
June 14, 2017DrugsFDA
Qualgen recalls Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Off
Hazard: CGMP deviations- Lack of Quality Assurance
June 14, 2017DrugsFDA
Qualgen recalls Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Of
Hazard: CGMP deviations- Lack of Quality Assurance
December 2, 2015DrugsFDA
Qualgen recalls Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761
Hazard: Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
December 2, 2015DrugsFDA
Qualgen recalls Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01
Hazard: Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.