CLASS I Drug recall · Reported 27 Aug 2014 · FDA Enforcement Report
DOBUTamine Injection, USP, 250 mg per Single-dose Fliptop Vial recalled
Hospira is recalling DOBUTamine Injection, USP, 250 mg per Single-dose Fliptop Vial, distributed nationwide in the US. The recall was initiated on 10 Jan 2014 and the FDA has classified it as Class I.
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-1540-2014
- FDA event ID
- 67354
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Dobutamine
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Jan 2014
- FDA classified
- 18 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Jan 2014 | Recall initiated by company | |
| 18 Aug 2014 | Classified by FDA | +220 days |
| 27 Aug 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Product as listed by the FDA
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Which lots are affected?
Lot # 27-352-DK; Exp 03/15
Where was it sold?
Nationwide and Puerto Rico.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 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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|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Dobutamine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DOBUTamine Injection, USP, 250 mg recalled by PfizerDobutamine | Pfizer | Other | Nationwide |
| Drug | CLASS II | Dobutamine, (a) 1080MG IN D5W, (b) 760MG IN D5W, ionotrop recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | DOBUTamine Injection, USP 250 mg/ Vial, For IV Use Only recalled | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Dobutamine 2000 mcg/mL in a) D5W-, b) D5W-, c) D5W recalled | Baptist Health Medical Towers Pharmacy and Infusion Services | Sterility | AR |
| Drug | CLASS II | Dobutamine HCL in D5W, Packaged as a) 240MG in Homepumps recalled | Sentara Enterprises | Sterility | NC, VA |