PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: July 2, 2025 Initiated: May 30, 2025 #D-0531-2025

Product Description

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

Reason for Recall

Marketed Without an Approved NDA/ANDA

Details

Units Affected
26 vials
Distribution
NY, NJ
Location
Elmsford, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Advanced Pharmaceutical Technology, Inc.. Units affected: 26 vials.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA
Which agency issued this recall?
This recall was issued by the FDA Drug on July 2, 2025. Severity: Moderate. Recall number: D-0531-2025.