Testosterone Cypionate Injection recalled over manufacturing violations

Recall date

April 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Eugia US LLC recalls Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC,…

Recall number

D-0363-2025

FDA classification

Class II

Brand / firm

Eugia US LLC

Sold / distributed

Nationwide USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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