Recall archive / FDA drug enforcement
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc... — FDA record D-0539-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 21, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- CGMP Deviations; potential temperature excursions due to transit delays
- Classification
- Class II
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 2 Pre-filled syringes
- Agency-reported status
- Ongoing
- Source record identifier
- D-0539-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: 1178382, Expiration date: 3/31/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Within the U.S - OH, VA, FL.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 30, 2025
- Recall initiation date
- Apr 21, 2025
- Center classification date
- Jul 21, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.