Testosterone is an androgen sold in the U.S. under 9 brand and generic names, for breast neoplasms, hypogonadism and delayed puberty. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Androgel (application NDA021015). Other testosterone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
for AndroGel 1% differs from AndroGel 1.62%. For dosage and administration of AndroGel 1.62% refer to its full prescribing information. ( 2 ) Prior to initiating AndroGel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Dosage and Administration for AndroGel 1% differs from AndroGel 1.62%. For dosage and administration of AndroGel 1.62% refer to its full prescribing information. ( 2 ) Prior to initiating AndroGel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). Starting dose of AndroGel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets or one 50 mg packet), applied once daily in the morning. ( 2.1 ) Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply AndroGel 1% to any other parts of the body including the genitals, chest, armpits (axillae), knees, or back. ( 2.2 ) Dose adjustment: AndroGel 1% can be dose adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of total serum testosterone concentration. The dose should be titrated based on the serum…
Most common adverse reactions (incidence ≥ 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ASCEND Therapeutics US, LLC at 1-877-204-1013 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Hypogonadal Men Table 2 shows the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with AndroGel 1% and reported by >1% of patients in a 180 Day, Phase 3 study. Table 2: Adverse Events Possibly, Probably or Definitely Related to Use of AndroGel 1% in the 180-Day Controlled Clinical Trial Adverse Event Dose of AndroGel 1% 50 mg 75 mg 100 mg N = 77 N = 40 N = 78 Acne 1% 3% 8% Alopecia 1% 0% 1% Application Site Reaction 5% 3% 4% Asthenia 0% 3% 1% Depression 1% 0% 1% Emotional Lability 0% 3% 3% Gynecomastia 1% 0% 3% Headache 4% 3% 0% Hypertension 3% 0% 3% Lab Test Abnormal* 6% 5% 3% Libido Decreased 0% 3% 1% Nervousness 0% 3% 1% Pain Breast 1% 3% 1% Prostate Disorder** 3% 3% 5% Testis Disorder*** 3% 0% 0% * Lab test abnormal occurred in nine…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Film | Generic | $1 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| E;640 | 1.25 mg / 2.5 mg | green | oval | — |
| C010 | 1.25 mg / 2.5 mg | yellow | capsule | — |
| C010 | 1.25 mg / 2.5 mg | yellow | oval | — |
| 1490 | 1.25 mg / 2.5 mg | green | capsule | — |
| 112 | 112.5 mg | white | capsule | — |
| MP100 | 100 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
AndroGel 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.1 ), and Nonclinical Toxicology ( 13.1 )]. AndroGel 1% is contraindicated in women who are pregnant. AndroGel 1% can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for transfer of testosterone from men treated with AndroGel 1%. If a pregnant woman is exposed to AndroGel 1%, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . Men with carcinoma of the breast or known or suspected prostate cancer ( 4 , 5.4 ) Women who are pregnant. Testosterone may cause fetal harm ( 4 , 8.1 )
Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. ( 7.2 ) Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended. ( 7.2 ) Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. ( 7.3 ) 7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease insulin requirements. 7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. 7.3 Corticosteroids The concurrent use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
| Not yet rated |
| Prescription |
| Topical |
| Generic |
| $1 |
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| 3 | Not yet rated | Prescription | Solution | Generic | $1 | View → |
| 4 | Not yet rated | Prescription | Topical | Generic | $1 | View → |
| 5 | Not yet rated | Prescription | Topical | Generic | $1 | View → |
| 6 | Not yet rated | Prescription | Tablet | Generic | $1 | View → |
| 7 | Not yet rated | Prescription | Topical | Generic | $1 | View → |
| 8 | Not yet rated | Prescription | Film | Generic | $1 | View → |
| 9 | Not yet rated | Prescription | Film | Generic | $1 | View → |
| white |
| capsule |
| — |
| MP150 | 150 mg | white | capsule | — |
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| MP200 | 200 mg | white | capsule | — |
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| 158 | 158 mg | red | capsule | — |
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| 198 | 198 mg | white | capsule | — |
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| 237 | 237 mg | orange | capsule | — |
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| E;639 | 0.625 mg / 1.25 mg | green | oval | — |
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