Hydromorphone Hydrochloride Injection — Class II drug recall D-1081-2017
Terminated recall by HOSPIRA INC, LAKE FOREST, reported 2017-08-16, distributed nationwide. Presence of Particulate Matter: Silicone oil
| Recall number | D-1081-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HOSPIRA INC, LAKE FOREST, LAKE FOREST, IL, United States |
| Recall initiated | 2017-07-26 |
| Classified | 2017-08-09 |
| Reported by FDA | 2017-08-16 |
| Terminated | 2018-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 9,009 vials |
| Reason classes | specification failure |
| NDC | 00409-2634, 00409-2634-01, 00409-2634-05, 00409-2634-10, 00409-2634-25, 00409-2634-50 |
| Lot numbers | 56260DD |
| Expiration dates | 2017-08-01 |
Product
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50
Reason for recall
Presence of Particulate Matter: Silicone oil
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-1081-2017. 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.