Home/Recalls/FDA-D-0258-2026
FDA DrugsClass II

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Ma...

Published: January 21, 2026Recall ID: D-0258-2026Category: drugsCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

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

Additional Source Details

FieldValue
CityElmsford
StateNY
Event id97821
Address 1132 S Central Ave
Code infoLot #: P-22-3, Exp 06-2027
Postal code10523-3509
Report date20260121
Product typeDrugs
Product quantity22,843 pellets
Reason for recallLack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251003
Initial firm notificationLetter
Center classification date20260114

Overview

  • Recalling FirmAdvanced Pharmaceutical Technology, Inc.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionGA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Official Agency Alert