FDA recall D-0258-2026

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-10-03

Report date

2026-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elmsford, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0258-2026