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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Testosterone Cypionate Injection Recalled for Persistent Crystals

Agency Publication Date: April 1, 2023
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Summary

Azurity Pharmaceuticals is recalling approximately 59,567 vials of Testosterone Cypionate Injection, USP, CIII (200 mg/mL), a prescription medication used to treat low testosterone levels. The recall was initiated because customers reported that crystals formed within the medication and would not dissolve back into the solution even after warming and shaking the vials. If you use this medication, you should consult your doctor or pharmacist to determine if your supply is affected.

Risk

Injecting a solution that contains undissolved crystals can cause serious health risks, including local irritation or inflammation at the injection site. If the crystals enter the bloodstream, they could potentially block small blood vessels, leading to more severe complications. No injuries or adverse events have been reported to date.

What You Should Do

  1. This recall involves Testosterone Cypionate Injection, USP, CIII (200 mg/mL) distributed under the Wilshire Pharmaceuticals label in 10 mL multiple-dose vials (NDC 52536-625-10) and 1 mL single-dose vials (NDC 52536-625-01).
  2. Check your medication for lot numbers 23804.034A, 23803.061A, or 23804 with an expiration date of 9/2024.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Testosterone Cypionate Injection, USP, CIII, 200 mg/mL
Variants: 10 mL multiple-dose vials, 1 mL single-dose vials
Lot Numbers:
23804.034A (Exp 9/2024)
23803.061A (Exp 9/2024)
23804 (Exp 9/2024)
NDC:
52536-625-10
52536-625-01

Distributed by Wilshire Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91710
Status: Resolved
Manufacturer: Azurity Pharmaceuticals, Inc.
Sold By: Wilshire Pharmaceuticals, Inc.; Pharmacies
Manufactured In: United States
Units Affected: a) 16,471 vials; b) 43,096 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.