EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only,… recall
FDA recall D-0539-2025 · initiated Apr 21, 2025
Mckesson Medical-Surgical Inc. Corporate Office recalled EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only… in Apr 2025 — an FDA Class II recall (D-0539-2025) because CGMP Deviations; potential temperature excursions due to transit delays.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; potential temperature excursions due to transit delays
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
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 Pre-filled syringes
Details
- Product
- EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
- Recalling company
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Within the U.S - OH, VA, FL.
- Initiated
- Apr 21, 2025
- FDA report date
- Jul 30, 2025
This recall is linked to a product we cover: Evenity →
Frequently asked
- Was EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only… recalled?
- Mckesson Medical-Surgical Inc. Corporate Office recalled EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only… in Apr 2025 — an FDA Class II recall (D-0539-2025) because CGMP Deviations; potential temperature excursions due to transit delays. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only… recalled?
- Per the FDA enforcement record, the reason for recall D-0539-2025 was: CGMP Deviations; potential temperature excursions due to transit delays
- Is a recalled EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only… 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 EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only… are affected?
- Distributed: Within the U.S - OH, VA, FL.. The recall covers these lots — Lot: 1178382, Expiration date: 3/31/2027. 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-0539-2025.