Qualgen recalls

Qualgen has 27 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 23 Jul 2025. 1 is still ongoing. The most frequent reason is sterility.

Total recalls27since 2015

Last 12 months0reported

Class I00% of total

Ongoing1latest 23 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 1 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 24 89%Class III 3 11%

Why qualgen is recalled

Product types

Injectable & IV Drugs1970%
Hormones & Birth Control830%

By year

202514%
20181659%
2017830%
201527%

Ongoing qualgen recalls

1 active

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025Drug	CLASS III	Testosterone 200 mg Pellet recalled by Qualgen	Qualgen	Packaging Defects	Nationwide

All qualgen recalls, newest first

27 total

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025Drug	CLASS III	Testosterone 200 mg Pellet recalled by Qualgen	Qualgen	Packaging Defects	Nationwide
14 Nov 2018Drug	CLASS II	Estradiol 10mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Estradiol 6 mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Testosterone 12.5mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Estradiol 25mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Testosterone 87.5mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Testosterone 200mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Testosterone 37.5 mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Estradiol 18mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Testosterone 200 mg/Anastrozole 20 mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Testosterone 100mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Estradiol 12.5mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Estradiol 15mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Testosterone 50mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
14 Nov 2018Drug	CLASS II	Testosterone 25 mg pellet recalled by Qualgen	Qualgen	Sterility	Nationwide
11 Jul 2018Drug	CLASS III	Testosterone 200 mg Pellet amber vial recalled by Qualgen	Qualgen	Other	Nationwide
11 Jul 2018Drug	CLASS III	Estradiol 20mg Pellet amber vial recalled by Qualgen	Qualgen	Other	Nationwide
14 Jun 2017Drug	CLASS II	Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF recalled	Qualgen	Manufacturing (CGMP) Deviations	Nationwide
14 Jun 2017Drug	CLASS II	Estradiol 6 mg pellet 99.5% Estradiol recalled by Qualgen	Qualgen	Manufacturing (CGMP) Deviations	Nationwide
14 Jun 2017Drug	CLASS II	Estradiol 25 mg pellet 99.5% Estradiol recalled by Qualgen	Qualgen	Manufacturing (CGMP) Deviations	Nationwide
14 Jun 2017Drug	CLASS II	Estradiol 18 mg pellet , 99.5% Estradiol recalled by Qualgen	Qualgen	Manufacturing (CGMP) Deviations	Nationwide
14 Jun 2017Drug	CLASS II	Estradiol 22 mg pellet 99.5% Estradiol recalled by Qualgen	Qualgen	Manufacturing (CGMP) Deviations	Nationwide
14 Jun 2017Drug	CLASS II	Estradiol 10 mg pellet 99.5% Estradiol recalled by Qualgen	Qualgen	Manufacturing (CGMP) Deviations	Nationwide
14 Jun 2017Drug	CLASS II	Estradiol 12.5 mg pellet 99.5% Estradiol recalled by Qualgen	Qualgen	Manufacturing (CGMP) Deviations	Nationwide
14 Jun 2017Drug	CLASS II	Estradiol 20 mg pellet 99.5% Estradiol recalled by Qualgen	Qualgen	Manufacturing (CGMP) Deviations	Nationwide
2 Dec 2015Drug	CLASS II	Testosterone USP 99.5%, .5% Stearic Acid NF Pellets recalled by Qualgen	Qualgen	Sterility	Nationwide
2 Dec 2015Drug	CLASS II	Estradiol USP 99.5%, .5% Stearic Acid NF Pellets recalled by Qualgen	Qualgen	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.