DOBUTamine Injection — Class II drug recall D-1500-2016
Terminated recall by Hospira Inc., reported 2016-09-21, distributed nationwide. Discoloration: Firm received complaints of product discoloration and particulates.
| Recall number | D-1500-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-08-15 |
| Classified | 2016-09-14 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2019-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS |
| Quantity | 24,000 vials |
| Reason classes | specification failure |
| NDC | 00409-2025-20 |
| Lot numbers | 52175DD |
| Expiration dates | 2016-10-01 |
Product
DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
Reason for recall
Discoloration: Firm received complaints of product discoloration and particulates.
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-1500-2016. 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.