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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

TESTO-200 Testosterone Cypionate Injection Recalled for Lack of FDA Approval

Agency Publication Date: June 20, 2025
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Summary

Advanced Pharmaceutical Technology, Inc. is recalling 26 vials of TESTO-200 (testosterone cypionate injection) 2000mg/10ml because the product is being marketed without required FDA approval. The recall involves specific 10ml multidose vials from lot P-24-1 with an expiration date of February 28, 2027. Because the product has not been reviewed by the FDA, its safety, quality, and effectiveness have not been verified for medical use.

Risk

Unapproved drugs pose a significant safety risk because they have not undergone the rigorous FDA evaluation process to ensure they are safe, pure, and effective. There is a risk that the product may not meet manufacturing standards for sterile injectable medications.

What You Should Do

  1. This recall affects TESTO-200 (testosterone cypionate injection) 2000mg/10ml (200mg/ml) packaged in cartons containing one 10ml multidose vial.
  2. Identify the affected product by looking for NDC 57377-200-01 and Lot P-24-1 with an expiration date of 02/28/2027 printed on the label or carton.
  3. If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Advanced Pharmaceutical Technology, Inc. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

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: TESTO-200, Testosterone Cypionate Injection USP (2000mg/10ml)
Variants: 200mg/ml, 10ml multidose vial
Lot Numbers:
P-24-1 (Exp. 02/28/2027)
NDC:
57377-200-01

Intramuscular injection only. Rx Only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96981
Status: Active
Manufacturer: Advanced Pharmaceutical Technology, Inc.
Manufactured In: United States
Units Affected: 26 vials
Distributed To: New York, New Jersey
Agency Last Updated: July 16, 2025

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.