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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-100 CIII Testosterone Pellets Recalled for Sterility Concerns

Agency Publication Date: January 14, 2026
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Summary

Advanced Pharmaceutical Technology, Inc. is recalling 22,843 units of TESTO-100 CIII (testosterone 100 mg) sterile pellets because of a lack of assurance of sterility. This means there is a potential for microbial contamination in the subcutaneous pellets, which are implanted under the skin. The affected products were distributed in several states and internationally, and the recall involves a specific lot with an expiration date of June 2027.

Risk

A lack of sterility assurance in an implanted product poses a risk of infection or other serious health complications at the site of administration or systemically.

What You Should Do

  1. If you have health concerns, contact your healthcare provider or pharmacist.
  2. Identify if your product is affected by checking the label for TESTO-100 CIII (testosterone 100 mg), NDC# 57377-100-01, and Lot # P-22-3 with an expiration date of 06-2027.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Advanced Pharmaceutical Technology, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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: TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton
Variants: 100 mg, Subcutaneous pellet
Lot Numbers:
P-22-3 (Exp 06-2027)
NDC:
57377-100-01

Recall #: D-0258-2026; Quantity: 22,843 pellets

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97821
Status: Active
Manufacturer: Advanced Pharmaceutical Technology, Inc.
Sold By: Healthcare providers; Specialty pharmacies
Manufactured In: United States
Units Affected: 22,843 pellets
Distributed To: Georgia, New York, Texas, Puerto Rico

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.