Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Prolia (denosumab) Injection Recalled by Amgen, Inc. Due to Presence of Particulate Matter: Visible cellulose fibers were...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Amgen, Inc. directly.
Affected Products
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.
Quantity: 4,163 prefilled syringes
Why Was This Recalled?
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Amgen, Inc.
Amgen, Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report