TESTOSTERONE CYPIONATE Recall D-0363-2025
Description: 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
TESTOSTERONE CYPIONATE Recall D-0363-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0363-2025 |
| Event ID | 96680 |
| Brand | TESTOSTERONE CYPIONATE |
| Generic Name | TESTOSTERONE CYPIONATE |
| Manufacturer | TESTOSTERONE CYPIONATE |
| Original Package? | 1 |
| Active Substance | TESTOSTERONE CYPIONATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide USA |
| Quantity | 36,816 vials |
| Recall Reason | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. |
| Drug Classification | Class II |
| Drug Code Info | 20250423 |
| Product NDC | 55150-276 55150-277 55150-278 |
| Drug UPC | 0355150276011 0355150278015 0355150277018 |
| Recall Initiation Date | 20250410 |
| Report Date | 20250423 |
| Classification Date | 20250414 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Eugia US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | M0XW1UBI14 |
| Drug Application Number | ANDA211817 |
| Structured Product Labeling (SPL ID) | f408b7f9-eee2-4c06-9689-3b50dd182323 |
| Structured Product Labeling (SPL Set ID) | f901e2b2-f143-4237-8e95-0d134585490b |
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