Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Is Testosterone recalled?
Yes — there is an active recall. 69 ongoing FDA recalls mention Testosterone (406 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. Checked against openFDA on Oct 10, 2026.
Testosterone recalls on record
none so far in 2026; 406 on record, newest first
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
SIH-Testosterone Cyp. 20 mg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIH-Testosterone Cyp. 200 mg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
Testosterone Tri-Blend 200 mg/ml
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Cypionate 40 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Cypionate 250 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Cypionate 40 mg/ml
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Cypionate 220 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Cypionate 250 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Cypionate 50 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone 87.5 mg Sterile Pellet
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone 70 mg
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone 60 mg
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone 37.5 mg
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone 30 mg
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone 25 mg
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone 200 mg
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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