October 2025 FDA Recall Drug by Advanced Pharmaceutical Technology, Inc.
D-0258-2026 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Advanced Pharmaceutical Technology, Inc. on October 3, 2025 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece and the recall is currently ongoing.

Recall Number: D-0258-2026

Reason for Recall
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Initiated
10-03-2025
Reported
01-21-2026
Quantity
22,843 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97821
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharmaceutical Technology, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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