PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: April 23, 2025 Initiated: April 10, 2025 #D-0363-2025

Product 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

Reason for Recall

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Details

Recalling Firm
Eugia US LLC
Units Affected
36,816 vials
Distribution
Nationwide USA
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Eugia US LLC. Units affected: 36,816 vials.
Why was this product recalled?
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 23, 2025. Severity: Moderate. Recall number: D-0363-2025.