FDA Drug recall D-0363-2025
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manu…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manu… by Eugia Us, citing cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0363-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-10 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eugia Us |
| Distribution | US |
Product
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
Reason
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Identifiers
| ndc | 55150-276-01 |
|---|---|
| ndc | 55150-277-01 |
| ndc | 55150-278-01 |
| code_info | Lot #: 1TC24075A, Exp 11/30/2026. |
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-0363-2025%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.