PROLIA Injection (Mckesson) - Temperature Excursion (2025)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Brand
Mckesson Medical-Surgical Inc. Corporate Office
Lot Codes / Batch Numbers
Lot: 1180924, Expiration date: 6/30/2027.
Products Sold
Lot: 1180924, Expiration date: 6/30/2027.
Mckesson Medical-Surgical Inc. Corporate Office is recalling PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen I due to CGMP Deviations; potential temperature excursions due to transit delays. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations; potential temperature excursions due to transit delays
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, OH, VA
Page updated: Jan 7, 2026