FDA Drug recall D-0531-2025
TESTO-200, Testosterone Cypionate Inj
- FDA Drug
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of TESTO-200, Testosterone Cypionate Inj by Advanced Pharmaceutical Technology, citing marketed Without an Approved NDA/ANDA.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0531-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-30 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Pharmaceutical Technology |
| Distribution | NJ, NY |
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
Reason
Marketed Without an Approved NDA/ANDA
Identifiers
| code_info | Lot P-24-1; Exp. 02/28/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0531-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.