FDA Drugs recall ·
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only… recall
- Recall number
- D-0363-2025
- Date
- (initiated April 10, 2025)
- Company / brand
- Eugia US LLC
279 Princeton Hightstown Rd, East Windsor, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 36,816 vials
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 1TC24075A, Exp 11/30/2026.
Distribution
Nationwide USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0363-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.