Amgen's Prolia Injection Recalled Over Temperature Excursion Risks
A nationwide Class II recall has been initiated for Prolia (denosumab) 60 mg/mL injection, manufactured by Amgen Inc. and distributed by McKesson Medical-Surgical Inc. The affected product, packaged in 6 pre-filled syringes under lot number 1180924 with an expiration date of June 30, 2027, was distributed across Ohio, Virginia, and Florida. The recall, identified under Recall Number D-0538-2025, was voluntarily initiated on April 21, 2025, and remains ongoing, according to the US Food and Drug Administration (FDA) Enforcement Report.
The recall has been classified as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The initial cause cited was Current Good Manufacturing Practice (CGMP) deviations, and the reason was later updated on July 29, 2025, to include potential temperature excursions due to transit delays, which could compromise the product’s safety, efficacy, or shelf life. Although no press release was issued, consignees were notified via formal letters.
Prolia is a prescription-only injectable medication used for the treatment of osteoporosis in postmenopausal women and in men at high risk for fractures, especially when other treatments have failed or are not suitable. It is also indicated for bone loss associated with certain types of cancer therapy. Given the product’s sensitivity to temperature and its role in bone density preservation, pharmacists and health care providers should immediately identify and quarantine the affected lot to prevent any potential patient harm.
