Drug FDA Class II Ongoing cGMP deviation

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

Eugia US LLC Published Apr 23, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Eugia US LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Crystalline Precipitate Formation · primary

Affected products (1)

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

TESTOSTERONE CYPIONATE · 36,816 vials

NDC: 55150-276, 55150-277, 55150-278, 55150-276-01, 55150-277-01, 55150-278-01

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

Affected areas

Nationwide

Timeline

Initiated

Apr 10, 2025
Published

Apr 23, 2025

Recall number: D-0363-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.