TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Ad...

FDA Recall #D-0258-2026 — Class II — October 3, 2025

Recall #D-0258-2026 Date: October 3, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Advanced Pharmaceutical Technology, Inc. — Elmsford, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

22,843 pellets

Distribution

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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated