May 2025 FDA Recall Drug by Advanced Pharmaceutical Technology, Inc.
D-0531-2025 - Marketed Without an Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Advanced Pharmaceutical Technology, Inc. on May 30, 2025 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in NY, NJ and the recall is currently ongoing.

Recall Number: D-0531-2025

Reason for Recall
Marketed Without an Approved NDA/ANDA
Initiated
05-30-2025
Reported
07-02-2025
Quantity
26 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96981
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.
NY, NJ
Product Description About Product Description
Full technical description of the product.
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01

Batch or Lot Expiration Information

Lot# Lot P-24-1; Exp. 02/28/2027