Prolia — Class II drug recall D-66318-001
Terminated recall by Amgen, Inc., reported 2013-11-13, distributed nationwide. Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes
| Recall number | D-66318-001 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amgen, Inc., Thousand Oaks, CA, United States |
| Recall initiated | 2013-09-17 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-06-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 4,163 prefilled |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00355513710015 |
| NDC | 55513-0710, 55513-0710-01, 55513-0710-21 |
| Lot numbers | 07/15, 1037592 |
Product
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.
Reason for recall
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-66318-001. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.