Testosterone Cypionate Injection recalled over sterility concerns

Recall date

May 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Empower Clinic Services, LLC dba Empower Pharmacy recalls Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pha…

Recall number

D-0420-2025

FDA classification

Class II

Brand / firm

Empower Clinic Services, LLC dba Empower Pharmacy

Sold / distributed

USA Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.