Eugia US LLC: Drug Recall

Recall #D-0363-2025 · 04/10/2025

Class II: Risk

Recall Details

Recall Number: D-0363-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Eugia US LLC
Status: Ongoing
Date Initiated: 04/10/2025
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 36,816 vials

Reason for Recall

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

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

Distribution Pattern

Nationwide USA

Other Recalls by Eugia US LLC

Class II: Risk 05/29/2025

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 12/27/2024

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II: Risk 12/18/2024

CGMP Deviations

View all recalls by Eugia US LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.