CLASS I ONGOING Drug recall · Reported 31 May 2017 · FDA Enforcement Report
Infant 25% Dextrose Injection recalled by Hospira
Hospira is recalling Infant 25% Dextrose Injection, USP (250 mg/mL) Unit of Use Single-dose Syringe per, distributed nationwide in the US. The recall was initiated on 21 Apr 2017 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-0862-2017
- FDA event ID
- 77111
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Dextrose
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Apr 2017
- FDA classified
- 24 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Apr 2017 | Recall initiated by company | |
| 24 May 2017 | Classified by FDA | +33 days |
| 31 May 2017 | 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
Presence of Particulate Matter: human hair found within an internal sample syringe.
Product as listed by the FDA
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Infant 25% Dextrose Injection, USP (250 mg/mL) Unit of Use Single-dose Syringe per recalled?
Yes. Hospira recalled Infant 25% Dextrose Injection, USP (250 mg/mL) Unit of Use Single-dose Syringe per on 21 Apr 2017. The recall is Class I and its status is Ongoing. Recall number D-0862-2017.
Why was it recalled?
Presence of Particulate Matter: human hair found within an internal sample syringe.
Which lots are affected?
Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02
Where was it sold?
Nationwide in the USA 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 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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|---|---|---|---|---|---|
| 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 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 |
| Drug | CLASS II | DOBUTamine Injection, USP 250 mg/ Vial, For IV Use Only recalled | Hospira | Particulate Matter | Nationwide |
Other Dextrose Monohydrate recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP ADD-Vantage Unit recalled by PfizerDextrose | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | 25% Dextrose Injection, USP (250 mg/mL) Single-dose recalled by PfizerDextrose | Pfizer | Other | Nationwide |