Quick answers
- What is Testosterone used for?
- The FDA-approved label (Vogelxo, Upsher-Smith Laboratories, LLC, July 14, 2025) says: “Vogelxo is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Testosterone have a boxed warning?
- Yes. The FDA label for Vogelxo has a boxed warning (“WARNING: SECONDARY EXPOSURE TO TESTOSTERONE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Testosterone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Testosterone been recalled?
- FDA enforcement reports list 10 recalls of products of this medicine; the newest started November 7, 2025 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Testosterone?
- 16 companies list prescription products of Testosterone in the FDA NDC Directory, including Bryant Ranch Prepack, Actavis Pharma, Inc. and Upsher-Smith Laboratories, LLC.
What Testosterone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Vogelxo is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. …
— FDA label: Vogelxo, Upsher-Smith Laboratories, LLC, effective July 14, 2025. Read the full label on DailyMed →
The FDA has 36 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
. Read it on the full label →
33 of 36 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Gel · Gel, metered · Solution · Pellet |
|---|---|
| Route | Topical · Transdermal · Nasal · Subcutaneous |
| Prescription products | 48 in the FDA NDC Directory |
| Brand names | Vogelxo, Natesto Nasal Gel, Testopel, Testim |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| testosterone 1% gel | Generic | $0.4325–$1.11 per gram 6 packages, lowest to highest |
| testosterone 1.62% gel | Generic | $0.4715–$1.77 per gram 7 packages, lowest to highest |
| testosterone 12.5 mg gel, metered | Generic | $0.8046 per gram |
| testosterone 12.5 mg/1.25 g gel | Generic | $0.8046 per gram |
| testosterone 20.25 mg/1.25 g gel | Generic | $4.08 per gram |
| testosterone 20.25 mg/1.25 g gel, metered | Generic | $0.4715 per gram |
| testosterone 25 mg/2.5 g gel | Generic | $1.11 per gram |
| testosterone 30 mg/1.5 mL solution | Generic | $0.5429 per mL |
| testosterone 40.5 mg/2.5 g gel | Generic | $1.77 per gram |
| testosterone 5.5 mg/0.122 g gel, metered | Brand: Natesto nasal gel | $41.22 per gram |
| testosterone 50 mg/5 g gel | Generic | $0.4325–$0.7687 per gram 5 packages, lowest to highest |
| testosterone 50 mg/5 g gel | Brand: Testim | $3.78 per gram |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack8 products
- Actavis Pharma, Inc.7 products
- Upsher-Smith Laboratories, LLC5 products
- Prasco Laboratories5 products
- Padagis Israel Pharmaceuticals Ltd4 products
- NorthStar Rx LLC3 products
- Encube Ethicals, Inc.3 products
- Lupin Pharmaceuticals, Inc.2 products
- Alembic Pharmaceuticals Inc.2 products
- Endo USA, Inc.2 products
- Strides Pharma Science Limited2 products
- Acerus Pharmaceuticals Corporation1 product
- Xiromed, LLC1 product
- Amneal Pharmaceuticals NY LLC1 product
- Cipla USA Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021015 ANDROGEL | Besins Hlthcare | February 28, 2000 | 33, latest July 11, 2025 2025: Labeling · 2019: REMS · 2019: Labeling |
| NDA021454 TESTIM | Endo Operations | October 31, 2002 | 16, latest July 11, 2025 2025: Labeling · 2021: Labeling · 2021: Labeling |
| NDA022309 ANDROGEL | Besins Hlthcare | April 29, 2011 | 16, latest July 11, 2025 2025: Labeling · 2019: REMS · 2019: Labeling |
| NDA204399 VOGELXO | Upsher Smith Labs | June 4, 2014 | 7, latest July 11, 2025 2025: Labeling · 2020: Labeling · 2019: REMS |
| NDA205488 NATESTO | Acerus | May 28, 2014 | 3, latest July 11, 2025 2025: Labeling · 2016: Labeling · 2015: Labeling |
Generic approvals (20)
- ANDA080911Endo Operations · July 13, 1972
- ANDA076737Actavis Labs Ut Inc · January 27, 2006
- ANDA076744Strides Pharma Intl · May 23, 2007
- ANDA204268Padagis Israel · August 4, 2015
- ANDA204255Padagis Israel · February 28, 2017
- ANDA205781Padagis Israel · July 12, 2017
- ANDA205328Actavis Labs Ut Inc · August 7, 2017
- ANDA091073Actavis Labs Ut Inc · September 18, 2017
- ANDA208061Lupin · October 23, 2017
- ANDA209533Cipla · January 29, 2018
- ANDA204570Actavis Labs Ut Inc · April 10, 2019
- ANDA207373Amneal · April 10, 2019
- ANDA208560Lupin · April 10, 2019
- ANDA208620Encube · April 10, 2019
- ANDA209390Twi Pharms · September 23, 2019
- ANDA210835Xiromed · April 16, 2020
- ANDA212301Encube · January 11, 2021
- ANDA213922Alembic · March 3, 2021
- ANDA212882Alembic · June 14, 2021
- ANDA212984Encube · November 9, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 7, 2025 · Class III · Ongoing · D-0198-2026
Defective Container - A defect in the side-seal which allows leakage of product.
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ — Teva Pharmaceuticals USA, Inc
-
March 5, 2025 · Class II · Ongoing · D-0294-2025
Presence of foreign substance: Presence of Benzene.
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02 — Strides Pharma, Inc.
-
March 5, 2025 · Class II · Ongoing · D-0293-2025
Presence of foreign substance: Presence of Benzene.
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 — Strides Pharma, Inc.
-
August 8, 2024 · Class II · Ongoing · D-0637-2024
Superpotent Drug
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30 — Teva Pharmaceuticals USA, Inc
-
November 10, 2023 · Class III · Terminated · D-0127-2024
OOS for viscosity
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30 — Teva Pharmaceuticals USA, Inc
-
June 29, 2022 · Class II · Terminated · D-1289-2022
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharm — Teva Pharmaceuticals USA Inc
-
November 11, 2020 · Class III · Terminated · D-0100-2021
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt L — Teva Pharmaceuticals USA
-
June 12, 2019 · Class III · Terminated · D-1454-2019
Defective Container; actuator may improperly function and affect dose delivery.
Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: C — InvaGen Pharmaceuticals, Inc.
-
March 13, 2019 · Class III · Terminated · D-1010-2019
Defective Container: Repetitive complaints received indicating pump not working.
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC — Lupin Pharmaceuticals Inc.
-
October 9, 2018 · Class III · Terminated · D-0087-2019
Defective Container: Repetitive complaints received indicating pump not working.
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC — Lupin Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 318240, 404405, 1596780, 1596782, 1596784, 1596785, 1597076, 1597120, 1597123, 1597126 … (+4) |
|---|---|
| SPL set ID of the quoted label | 2dd150f6-cdfd-4d51-8888-12b288f26262 |
| FDA labels (SPL) | 36 |
| FDA applications | NDA021015, NDA021454, NDA022309, NDA204399, NDA205488, 20 ANDA |
| Active ingredients (FDA) | TESTOSTERONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vogelxo, Upsher-Smith Laboratories, LLC, effective July 14, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →