April 2025 FDA Recall Testosterone Cypionate by Eugia Us Llc
D-0363-2025 - cGMP
This Class II drug recall was voluntarily initiated by Eugia Us Llc on April 10, 2025 for the product Testosterone Cypionate. The FDA reported the reason for recall as cgmp. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0363-2025
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
04-10-2025
04-23-2025
36,816 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eugia US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 1TC24075A, Exp 11/30/2026.
