Amgen Recalls Prolia Syringes Due to Particulate Matter
Amgen recalls specific lots of Prolia (denosumab) prefilled syringes due to visible cellulose fibers. Check your lot number and expiration date for details.
Use caution until it’s fixed
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Contact the company
What happened, in plain English
Amgen, Inc. is recalling a small number of Prolia (denosumab) Injection prefilled syringes because visible cellulose fibers were found in them during quality checks. The affected product is distributed nationwide, in Puerto Rico, Canada, Mexico, and through clinical channels in Europe. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/46593-amgen-inc-recalls-prolia-denosumab-injection-60-mg-ml-1.
Source Summary by GovInfoNow · govinfonow.com/recall/46593-amgen-inc-recalls-prolia-denosumab-injection-60-mg-ml-1 · Updated October 13, 2026 · FDA enforcement record: FDA #D-66318-001
Cite this page
“Amgen Recalls Prolia Syringes Due to Particulate Matter.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46593-amgen-inc-recalls-prolia-denosumab-injection-60-mg-ml-1. Based on FDA recall #D-66318-001 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66318-001%22&limit=1).
Why it’s dangerous
Visible cellulose fibers were observed in a small number of prefilled syringes during routine quality examinations. This indicates the presence of particulate matter in the drug product, which could potentially cause adverse reactions if injected.
Who’s affected
Patients prescribed Prolia (denosumab) Injection who possess syringes from the specific lot number and expiration date listed below. The risk is associated with the presence of particulate matter in these specific units.
How to tell if you have this one
Check your prefilled syringe for the following details: Product name Prolia (denosumab) Injection, 60 mg/mL; NDC 55513-710-01; UPC 3 55513 71001 5. Specifically look for Lot # 1037592 with an expiration date of 07/15.
- Brand
Amgen- Product
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by- Category
Drug
What to do — step by step
Check Your Syringe Details
Verify if your Prolia syringe matches NDC 55513-710-01, UPC 3 55513 71001 5, Lot # 1037592, and Exp 07/15.
Contact Your Healthcare Provider
Since no remedy is stated in the record, consult your doctor or pharmacist for guidance on what to do with the affected syringes.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-66318-001 (September 17, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-66318-001 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.