FDA recall, , Moderate risk
Advanced Pharmaceutical Technology TESTO-100 CIII Testosterone Pellets
Testo-100 Ciii (testosterone 100 mg) pellets may lack assurance of sterility due to potential microbial contamination.
Summary by Recall Canary from the FDA notice
What happened
Advanced Pharmaceutical Technology, Inc. of Elmsford, New York, began a recall on October 3, 2025, of Testo-100 Ciii (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, due to a lack of assurance of sterility from potential microbial contamination of subcutaneous pellets.
The FDA added the recall to its Enforcement Report and classified it on January 14, 2026, with the weekly report on January 21, 2026. The product was distributed in Georgia, New York, Texas, Puerto Rico, the United Kingdom, Malta, and Greece, with 22,843 pellets recalled.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your carton affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Testo-100 Ciii (testosterone 100 mg), 10 Sterile Pellets per carton
- NDC
- 57377-100-01
- Lot code
- P-22-3
Recall details
- Company began the recall
- Company
- Advanced Pharmaceutical Technology, Inc.Elmsford, New York
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97821
- Recall number
- D-0258-2026
- Quantity recalled
- 22,843 pellets
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
