Recalls / Class II
Class IID-0363-2025
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
- Brand name
- Testosterone Cypionate
- Generic name
- Testosterone Cypionate
- Active ingredient
- Testosterone Cypionate
- Route
- Intramuscular
- NDCs
- 55150-276, 55150-277, 55150-278
- FDA application
- ANDA211817
- Affected lot / code info
- Lot #: 1TC24075A, Exp 11/30/2026.
Why it was recalled
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 36,816 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2025-04-10
- FDA classified
- 2025-04-14
- Posted by FDA
- 2025-04-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0363-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.