FDA Recall D-0363-2025

Eugia US LLC · East Windsor, NJ

Class II Ongoing 399 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: 1TC24075A, Exp 11/30/2026.

Quantity: 36,816 vials

Reason for recall

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

Recall record

Recall number: D-0363-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA
Recall initiated: 2025-04-10
Classified by FDA Center: 2025-04-14
FDA published: 2025-04-23
Recalling firm: Eugia US LLC
Firm location: East Windsor, NJ

Drug identification

Brand name(s): TESTOSTERONE CYPIONATE
Generic name(s): TESTOSTERONE CYPIONATE
Manufacturer(s): Eugia US LLC
NDC(s): 55150-276, 55150-277, 55150-278
Route(s): INTRAMUSCULAR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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