Class II Recall Issued for Evenity Injection Due to CGMP and Temperature Control Issues
A Class II recall has been issued for Evenity (romosozumab-aqqg) injection, 105 mg/1.17 mL, due to potential current good manufacturing practice (CGMP) deviations. The recall specifically involves a single lot (1178382, expiring 03/31/2027) of this subcutaneous injectable product manufactured by Amgen Inc. The concern stems from potential temperature excursions during transit, likely caused by shipping delays. The affected product is packaged in units of two pre-filled syringes and carries the National Drug Code (NDC) 55513-880-02.
The recall, initiated voluntarily by McKesson Medical-Surgical Inc. on April 21, 2025, remains ongoing and affects distribution in Ohio, Virginia, and Florida. Though no press release has been issued, the US Food and Drug Administration classified this as a Class II recall on July 21, 2025, indicating the product may cause temporary or medically reversible adverse health consequences, with remote probability of serious harm. Notification to consignees was made via letter. The event is listed under Event ID 97110, with the recall number D-0539-2025.
Evenity is a prescription medication indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. The drug is a sclerostin inhibitor that helps to increase bone formation and, to a lesser extent, decrease bone resorption, offering an important treatment option for patients who have failed or are intolerant to other therapies. Pharmacists should remain alert for product from the affected lot and follow appropriate return or disposal instructions if in possession of the recalled inventory.
