Testosterone Cypionate Injection recall
FDA recall D-0420-2025 · initiated May 2, 2025
Empower Clinic Services, LLC dba Empower Pharmacy recalled Testosterone Cypionate Injection in May 2025 — an FDA Class II recall (D-0420-2025) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8,230 vials
Details
- Product
- 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.
- Recalling company
- Empower Clinic Services, LLC dba Empower Pharmacy
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- May 2, 2025
- FDA report date
- May 21, 2025
Frequently asked
- Was Testosterone Cypionate Injection recalled?
- Empower Clinic Services, LLC dba Empower Pharmacy recalled Testosterone Cypionate Injection in May 2025 — an FDA Class II recall (D-0420-2025) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Testosterone Cypionate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0420-2025 was: Lack of Assurance of Sterility
- Is a recalled Testosterone Cypionate Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Testosterone Cypionate Injection are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 202364, Exp 5/28/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0420-2025.