FDA recall D-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

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status

Ongoing

Initiation date

2025-04-10

Report date

2025-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0363-2025