The Recall Desk

Manufacturer

Qualgen, LLC

17 recalls in our database name Qualgen, LLC as the manufacturing or recalling firm.

What the numbers show

Total
17
Critical
0
Severe
8
Most recent
2025-07-23

Of the 17 recalls from Qualgen, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (47%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

  • LowFDA (Drugs)·D-0517-2025·2025-07-23

    Compounded testosterone pellet vials carry incorrect lot numbers from printing issue

    Compounded Testosterone 200 mg Pellet in 1 mL amber vials is being recalled because a printing issue resulted in incorrect lot numbers on the label. 2,832 vials are affected.

    Product
    Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0237-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 87.5mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2019·2018-11-14

    Qualgen Testosterone and Anastrozole Pellets Recalled for Sterility Concerns

    Qualgen, LLC is recalling Testosterone 200 mg/Anastrozole 20 mg pellets due to a lack of assurance of sterility. The recall affects specific vial sizes distributed nationwide.

    Product
    Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0230-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 6 mg pellets nationwide because the company cannot ensure the product is sterile.

    Product
    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 (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0233-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 200mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling Estradiol 12.5mg pellets nationwide because the company cannot ensure the product is sterile.

    Product
    Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 10mg pellets nationwide due to a lack of assurance of sterility. The affected lots have specific expiration dates.

    Product
    Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 15mg pellets because the company cannot ensure the products are sterile. The recall covers specific lots distributed nationwide.

    Product
    Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0229-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 25mg pellets because the company cannot assure the sterility of the product. The recall covers specific lots distributed nationwide.

    Product
    Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0231-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 100mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0235-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 37.5 mg pellets nationwide due to a lack of assurance of sterility.

    Product
    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 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling Estradiol 18mg pellets because the company cannot assure the sterility of the product. The recall covers specific vial sizes distributed nationwide.

    Product
    Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2019·2018-11-14

    Recall of Testosterone 12.5mg Pellet due to Sterility Concerns

    Qualgen, LLC is recalling Testosterone 12.5mg pellets nationwide because the sterility of the product cannot be assured. Consumers should stop using the affected lots and contact the manufacturer or pharmacist.

    Product
    Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0234-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 25 mg pellets nationwide because the company lacks assurance of sterility for these products.

    Product
    Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0236-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 50mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0893-2018·2018-07-11

    Qualgen Recalls Testosterone Pellets Due to Incorrect Lot and Expiration Dates

    Qualgen, LLC is recalling Testosterone 200 mg Pellets because the vials have incorrect or missing lot and expiration dates.

    Product
    TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0892-2018·2018-07-11

    Qualgen Recalls Estradiol Pellets Due to Incorrect or Missing Lot and Expiration Dates

    Qualgen, LLC is recalling Estradiol 20mg Pellets because the vials have incorrect or missing lot and expiration dates.

    Product
    ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
    Category
    Drug
    Distribution
    Distributed nationwide