CLASS II Drug recall · Reported 2 Dec 2015 · FDA Enforcement Report

Testosterone USP 99.5%, .5% Stearic Acid NF Pellets recalled by Qualgen

Qualgen is recalling Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, one-count vials, 25 mg (, distributed nationwide in the US. The recall was initiated on 9 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: A005 Ex.: 10/30/2015; A008 Ex.: 11/01/2015; A010 Ex.: 11/06/2015; A012 Ex.: 11/07/2015; A015 Ex.: 11/08/2015; A018 Ex.: 11/13/2015; A022 Ex.: 11/14/2015; A024 Ex.: 11/16/2015; A026 Ex.: 11/20/2015; A029 Ex.: 11/21/2015; A033 Ex.: 11/23/2015; A038 Ex.: 11/24/2015; A040 Ex.: 11/27/2015; A041 Ex.: 11/28/2015; A045 Ex.: 12/03/2015; A046 Ex.: 11/30/2015; A047 Ex.: 12/04/2015; A052 Ex.: 12/12/2015; A055 Ex.: 12/13/2015; A058 Ex.: 12/18/2015; A059 Ex.: 12/19/2015; A061 Ex.: 12/24/2015

Quantity recalled10,885 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0387-2016
FDA event ID: 72401
Recalling firm: Qualgen, Edmond, OK
Classification: Class II
Status: Terminated
Recall initiated: 9 Oct 2015
FDA classified: 24 Nov 2015
Reported: 2 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

9 Oct 2015	Recall initiated by company
24 Nov 2015	Classified by FDA	+46 days
2 Dec 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lots: A005 Ex.: 10/30/2015; A008 Ex.: 11/01/2015; A010 Ex.: 11/06/2015; A012 Ex.: 11/07/2015; A015 Ex.: 11/08/2015; A018 Ex.: 11/13/2015; A022 Ex.: 11/14/2015; A024 Ex.: 11/16/2015; A026 Ex.: 11/20/2015; A029 Ex.: 11/21/2015; A033 Ex.: 11/23/2015; A038 Ex.: 11/24/2015; A040 Ex.: 11/27/2015; A041 Ex.: 11/28/2015; A045 Ex.: 12/03/2015; A046 Ex.: 11/30/2015; A047 Ex.: 12/04/2015; A052 Ex.: 12/12/2015; A055 Ex.: 12/13/2015; A058 Ex.: 12/18/2015; A059 Ex.: 12/19/2015; A061 Ex.: 12/24/2015

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 72401

This product is part of a recall event; the main page for the event is Estradiol USP 99.5%, .5% Stearic Acid NF Pellets recalled by Qualgen.

Reported	Class	Recall	Company	Reason	Where
2 Dec 2015	CLASS II	Estradiol USP 99.5%, .5% Stearic Acid NF Pellets recalled by Qualgen	Qualgen	Sterility	Nationwide

More recalls from Qualgen

All 27

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

Other Testosterone recalls

All 91

Reported	Class	Recall	Company	Reason	Where
18 Feb 2026Drug	CLASS II	Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet recalled	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg recalled	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Testosterone, 37.5 mg, 1 Sterile Pellet recalled	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Testosterone, 50.0 mg, 1 Sterile Pellet recalled	F.H. Investments Inc. (	Particulate Matter	Nationwide
18 Feb 2026Drug	CLASS II	Testosterone, 18.0 mg, 1 Sterile Pellet recalled	F.H. Investments Inc. (	Particulate Matter	Nationwide