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Is Testosterone recalled?

Yes — there is an active recall. 69 ongoing FDA recalls mention Testosterone (411 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Testosterone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.

Class II · Moderate risk Terminated Apr 17, 2017

EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By…

Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

Syntho Pharmaceuticals, Inc. NDC 15310-020-01 D-0377-2019

Class II · Moderate risk Terminated Apr 6, 2017

Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric…

Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Isomeric Pharmacy Solution, LLC D-0686-2017

Class II · Moderate risk Terminated Mar 24, 2017

Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd…

Reason cGMP Deviations; lack of quality assurance.

Qinhuangdao Zizhu Pharmaceutical, Co. NDC 44132-006-06 D-0658-2017

Class II · Moderate risk Terminated Mar 15, 2017

Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma…

Reason Presence of Particulate Matter

Sun Pharmaceutical Industries, Inc. NDC 62756-015-40 D-0611-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0307-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0306-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0305-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0304-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0303-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0302-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0301-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0300-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0299-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0298-2017

Class II · Moderate risk Ongoing Nov 17, 2016

Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Reason Lack of Assurance of Sterility

Tri-Coast Pharmacy D-0297-2017

Class III · Low risk Terminated Oct 12, 2016

Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West…

Reason Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame…

Pharm D Solutions, LLC D-0426-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0423-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0422-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0404-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0403-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0402-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0401-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0400-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Cypionate / Zinc Sulf in Grapeseed Oil Injectable, 200 mg/200 mcg/mL, 10 mL vial, Compounded by Wells Pharmacy…

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0399-2017

Class II · Moderate risk Terminated Sep 21, 2016

Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Reason Lack of Assurance of Sterility

Wells Pharmacy Network LLC D-0338-2017