CLASS II Drug recall · Reported 14 Aug 2024 · FDA Enforcement Report
Empower Pharmacy, Estradiol Cypionate Injection recalled
Empower Clinic Services is recalling Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL Sterile Multiple Dose Vial, For, distributed nationwide in the US. The recall was initiated on 2 Aug 2024 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-0630-2024
- FDA event ID
- 95079
- Recalling firm
- Empower Clinic Services, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2024
- FDA classified
- 8 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Aug 2024 | Recall initiated by company | |
| 8 Aug 2024 | Classified by FDA | +6 days |
| 14 Aug 2024 | Published in enforcement report | +6 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
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL Sterile Multiple Dose Vial, For recalled?
Yes. Empower Clinic Services recalled Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL Sterile Multiple Dose Vial, For on 2 Aug 2024. The recall is Class II and its status is Terminated. Recall number D-0630-2024.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 179338, Beyond use date: 08/14/2024
Where was it sold?
Nationwide within the United States
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 21 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 | Testosterone Cypionate Injection, 200 mg/mL, CIII recalled | Empower Clinic Services | Sterility | Nationwide |
| Drug | CLASS II | Ascorbic Acid Preserved Injection Solution recalled | Empower Clinic Services | Labeling Errors | Nationwide |