Empower Pharmacy recall
FDA recall D-0630-2024 · initiated Aug 2, 2024
EMPOWER CLINIC SERVICES LLC recalled Empower Pharmacy in Aug 2024 — an FDA Class II recall (D-0630-2024) 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: 2,797
Details
- Product
- 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
- Recalling company
- EMPOWER CLINIC SERVICES LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Aug 2, 2024
- FDA report date
- Aug 14, 2024
Frequently asked
- Was Empower Pharmacy recalled?
- EMPOWER CLINIC SERVICES LLC recalled Empower Pharmacy in Aug 2024 — an FDA Class II recall (D-0630-2024) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Empower Pharmacy recalled?
- Per the FDA enforcement record, the reason for recall D-0630-2024 was: Lack of Assurance of Sterility
- Is a recalled Empower Pharmacy 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 Empower Pharmacy are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 179338, Beyond use date: 08/14/2024. 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-0630-2024.