Quick answers
- What is Testosterone cypionate used for?
- The FDA-approved label (Azmiro, Azurity Pharmaceuticals, Inc., July 25, 2025) says: “AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Testosterone cypionate have a boxed warning?
- No. None of the 40 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Testosterone cypionate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Testosterone cypionate been recalled?
- FDA enforcement reports list 15 recalls of products of this medicine; the newest started April 10, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Testosterone cypionate?
- 21 companies list prescription products of Testosterone cypionate in the FDA NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc. and A-S Medication Solutions.
What Testosterone cypionate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome …
— FDA label: Azmiro, Azurity Pharmaceuticals, Inc., effective July 25, 2025. Read the full label on DailyMed →
The FDA has 40 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.
The label quoted above has no boxed warning.
0 of 40 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intramuscular |
| Prescription products | 61 in the FDA NDC Directory |
| Brand names | Depo-Testosterone, Azmiro |
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 cypionate 100 mg/mL injection | Generic | $4.32 per mL |
| testosterone cypionate 100 mg/mL injection, solution | Generic | $4.32 per mL |
| testosterone cypionate 100 mg/mL injection, solution | Brand: Depo-Testosterone | $6.92 per mL |
| testosterone cypionate 1000 mg/10 mL injection, solution | Generic | $4.32 per mL |
| testosterone cypionate 200 mg/mL injection | Generic | $3.52–$11.01 per mL 6 packages, lowest to highest |
| testosterone cypionate 200 mg/mL injection, solution | Generic | $2.42–$11.01 per mL 13 packages, lowest to highest |
| testosterone cypionate 2000 mg/10 mL injection, solution | Generic | $3.52 per mL |
NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and 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
- Asclemed USA, Inc.8 products
- A-S Medication Solutions6 products
- Pharmacia & Upjohn Company LLC4 products
- Eugia US LLC3 products
- Xiromed, LLC3 products
- Cipla USA Inc.3 products
- Hikma Pharmaceuticals USA Inc.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Padagis US LLC2 products
- Azurity Pharmaceuticals, Inc.2 products
- BPI Labs LLC2 products
- Proficient Rx LP2 products
- NuCare Pharmaceuticals, Inc.2 products
- Hospira, Inc.2 products
- Alvogen Inc.2 products
- Ajenat Pharmaceuticals LLC2 products
- Wilshire Pharmaceuticals1 product
- NuCare pgarmaceuticals, Inc.1 product
- Remedyrepack Inc.1 product
- NorthStar Rx LLC1 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 |
|---|---|---|---|
| NDA216318 AZMIRO | Azurity | June 2, 2022 | 3, latest July 11, 2025 2025: Labeling · 2024: Labeling · 2024: Labeling |
Generic approvals (10)
- ANDA085635Pfizer · July 25, 1979
- ANDA040530Padagis Us · January 31, 2005
- ANDA091244Hikma Farmaceutica · May 1, 2012
- ANDA201720Sun Pharm Inds Ltd · June 3, 2013
- ANDA207742Am Regent · June 16, 2017
- ANDA210362Cipla · June 19, 2018
- ANDA206368Wilshire Pharms Inc · April 24, 2019
- ANDA215351Xiromed · April 13, 2023
- ANDA211817Eugia Pharma · October 20, 2023
- ANDA219478Bpi Labs · September 3, 2026
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.
-
April 10, 2025 · Class II · Ongoing · D-0363-2025
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01 — Eugia US LLC
-
February 15, 2023 · Class II · Terminated · D-0489-2023
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atl — Azurity Pharmaceuticals, Inc.
-
June 21, 2022 · Class II · Terminated · D-1190-2022
cGMP - Water leakage
Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- — SUN PHARMACEUTICAL INDUSTRIES INC
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June 10, 2022 · Class II · Terminated · D-1154-2022
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., H — SUN PHARMACEUTICAL INDUSTRIES INC
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June 3, 2022 · Class II · Terminated · D-1153-2022
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., H — SUN PHARMACEUTICAL INDUSTRIES INC
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June 3, 2022 · Class II · Terminated · D-1176-2022
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda H — SUN PHARMACEUTICAL INDUSTRIES INC
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January 11, 2021 · Class III · Terminated · D-0242-2021
Incorrect Labeling: Incorrect lot number on secondary packaging
Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40 — SUN PHARMACEUTICAL INDUSTRIES INC
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January 14, 2020 · Class II · Terminated · D-0787-2020
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, — Sun Pharmaceutical Industries, Inc.
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January 14, 2020 · Class II · Terminated · D-0788-2020
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbur — Sun Pharmaceutical Industries, Inc.
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September 27, 2019 · Class III · Terminated · D-0167-2020
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01 — Arbor Pharmaceuticals Inc.
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March 22, 2019 · Class II · Terminated · D-1125-2019
Presence of Particulate Matter.
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Saw — InvaGen Pharmaceuticals, Inc.
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March 22, 2019 · Class II · Terminated · D-1123-2019
Presence of Particulate Matter.
Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Saw — InvaGen Pharmaceuticals, Inc.
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March 22, 2019 · Class II · Terminated · D-1124-2019
Presence of Particulate Matter.
Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite — InvaGen Pharmaceuticals, Inc.
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July 12, 2018 · Class II · Terminated · D-0977-2018
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, — Sun Pharmaceutical Industries, Inc.
-
March 15, 2017 · Class II · Terminated · D-0611-2017
Presence of Particulate Matter
Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40 — Sun Pharmaceutical Industries, 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Azmiro, Azurity Pharmaceuticals, Inc., effective July 25, 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 →