CLASS II Drug recall · Reported 13 Nov 2013 · FDA Enforcement Report
Prolia (denosumab) Injection, 60 mg/mL recalled by Amgen
Amgen is recalling Prolia (denosumab) Injection, 60 mg/mL, mg Single Use Prefilled Syringe per, distributed nationwide in the US. The recall was initiated on 17 Sep 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-66318-001
- FDA event ID
- 66318
- Recalling firm
- Amgen, Thousand Oaks, CA
- Brand
- Prolia
- Manufacturer
- Amgen, Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2013
- FDA classified
- 4 Nov 2013
- Reported
- 13 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Sep 2013 | Recall initiated by company | |
| 4 Nov 2013 | Classified by FDA | +48 days |
| 13 Nov 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Which lots are affected?
Lot #: 1037592, Exp 07/15
Where was it sold?
Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amgen
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 60mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 7.5mg recalled by AmgenCorlanor | Amgen | Other | Nationwide |
Other Denosumab recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |