Hydromorphone — Class I drug recall D-0597-2018
Terminated recall by Pfizer Inc., reported 2018-03-21, distributed nationwide. Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
| Recall number | D-0597-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2018-02-07 |
| Classified | 2018-03-14 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-08-07 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, sterility, packaging |
| NDC | 00409-2634, 00409-2634-01, 00409-2634-05, 00409-2634-10, 00409-2634-25, 00409-2634-50 |
| Lot numbers | 71330DD |
| Expiration dates | 2018-11-01 |
Product
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Reason for recall
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
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-0597-2018. 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.