Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: 1TC24075A, Exp 11/30/2026.
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0363-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 10, 2025
- FDA report date
- Apr 23, 2025
- Quantity
- 36,816 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0363-2025, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96680
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 1TC24075A, Exp 11/30/2026.
- Postal code
- 08520-1401
- Report date
- Apr 23, 2025
- Product type
- Drugs
- Recall number
- D-0363-2025
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 36,816 vials
- Reason for recall
- cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Apr 10, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 14, 2025