CLASS II Drug recall · Reported 21 Sep 2016 · FDA Enforcement Report
DOBUTamine Injection, USP 250 mg/ Vial, For IV Use Only recalled
Hospira is recalling DOBUTamine Injection, USP 250 mg/ Vial, For IV Use Only, Must be Diluted Prior to Use, 5, distributed nationwide in the US. The recall was initiated on 15 Aug 2016 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-1500-2016
- FDA event ID
- 74707
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2016
- FDA classified
- 14 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Aug 2016 | Recall initiated by company | |
| 14 Sep 2016 | Classified by FDA | +30 days |
| 21 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Firm received complaints of product discoloration and particulates.
Product as listed by the FDA
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
Where it was distributed
Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units. 30 units returned by customer and destroyed internally.
Questions about this recall
Is DOBUTamine Injection, USP 250 mg/ Vial, For IV Use Only, Must be Diluted Prior to Use, 5 recalled?
Yes. Hospira recalled DOBUTamine Injection, USP 250 mg/ Vial, For IV Use Only, Must be Diluted Prior to Use, 5 on 15 Aug 2016. The recall is Class II and its status is Terminated. Recall number D-1500-2016.
Why was it recalled?
Discoloration: Firm received complaints of product discoloration and particulates.
Which lots are affected?
Lot #: 52175DD, Exp 01 Oct 2016
Where was it sold?
Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units. 30 units returned by customer and destroyed internally.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Dobutamine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DOBUTamine Injection, USP, 250 mg/ 5 mg/mL) per Single-dose recalledDobutamine | Pfizer | Other | Nationwide |
| Drug | CLASS I | DOBUTamine Injection, USP, 250 mg per Single-dose Fliptop Vial recalledDobutamine | Hospira | Particulate Matter | Nationwide |