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.

FDA recall notice · announced July 30, 2025 · Mckesson Medical-surgical Inc. Corporate Office

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

CGMP Deviations; potential temperature excursions due to transit delays

Notes

Distribution: Within the U.S - OH, VA, FL.
Lot/code information: Lot: 1178382, Expiration date: 3/31/2027
Quantity: 2 Pre-filled syringes
Status: Ongoing
Products in this recall event:
- BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK. (D-0540-2025)
- PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21 (D-0538-2025)
- 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. (D-0539-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.