FDA Drugs recall ·

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton… recall

Recall number
D-0258-2026
Date
(initiated October 3, 2025)
Company / brand
Advanced Pharmaceutical Technology, Inc.
132 S Central Ave, Elmsford, NY, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
22,843 pellets
Hazard tags
Sterility Microbial contamination
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

Why was it recalled?

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot #: P-22-3, Exp 06-2027

Distribution

GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece

States: Georgia New York Puerto Rico Texas

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0258-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.