CLASS II ONGOING Drug recall · Reported 21 May 2025 · FDA Enforcement Report
Testosterone Cypionate Injection, 200 mg/mL, CIII recalled
Empower Clinic Services is recalling Testosterone Cypionate Injection, 200 mg/mL, CIII, distributed nationwide in the US. The recall was initiated on 2 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0420-2025
- FDA event ID
- 96808
- Recalling firm
- Empower Clinic Services, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 May 2025
- FDA classified
- 9 May 2025
- Reported
- 21 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 May 2025 | Recall initiated by company | |
| 9 May 2025 | Classified by FDA | +7 days |
| 21 May 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 202364, Exp 5/28/2025
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Empower Clinic Services
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Empower Pharmacy, Estradiol Cypionate Injection recalled | Empower Clinic Services | Sterility | Nationwide |
| Drug | CLASS II | Ascorbic Acid Preserved Injection Solution recalled | Empower Clinic Services | Labeling Errors | Nationwide |
Other Testosterone Cypionate recalls
All 130| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate | Azurity Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL-vial recalled | TMC Acquisition | Sterility | Nationwide |