TESTO-200 — Class II drug recall D-0531-2025
Ongoing recall by Advanced Pharmaceutical Technology, Inc., reported 2025-07-02, distributed in NJ, NY. Marketed Without an Approved NDA/ANDA
| Recall number | D-0531-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Pharmaceutical Technology, Inc., Elmsford, NY, United States |
| Recall initiated | 2025-05-30 |
| Classified | 2025-07-16 |
| Reported by FDA | 2025-07-02 |
| Distributed | NJ, NY |
| Quantity | 26 vials |
| Reason classes | unapproved product |
| NDC | 57377-0200-01 |
| Lot numbers | P-24-1 |
| Expiration dates | 2027-02-28 |
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 for recall
Marketed Without an Approved NDA/ANDA
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0531-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.