Qualgen, LLC: 11 recalls on record

Recalls filed with 1 agency: FDA (11).

First recall on record: July 11, 2018. Most recent: July 23, 2025.

Risk classification: Class II: 9 · Class III: 2

Most recent recalls

DateAgencyProduct
July 23, 2025FDATestosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qual…D-0517-2025
November 14, 2018FDATestosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 c…D-0235-2019
November 14, 2018FDAEstradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (…D-0227-2019
November 14, 2018FDATestosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 cou…D-0231-2019
November 14, 2018FDATestosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69…D-0238-2019
November 14, 2018FDATestosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 coun…D-0236-2019
November 14, 2018FDAEstradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (…D-0228-2019
November 14, 2018FDAEstradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count…D-0226-2019
November 14, 2018FDATestosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 cou…D-0233-2019
November 14, 2018FDATestosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125…D-0234-2019
July 11, 2018FDAESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bris…D-0892-2018

Questions about this company

How many recalls does Qualgen, LLC have?
Recalert has 11 U.S. recalls on record for Qualgen, LLC, published between July 11, 2018 and July 23, 2025.
What was the most recent Qualgen, LLC recall?
FDA recall D-0517-2025, published July 23, 2025: 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
Which agencies have handled Qualgen, LLC recalls?
Qualgen, LLC appears as the recalling firm in recalls from: FDA (11).

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