CLASS I Drug recall · Reported 11 Feb 2015 · FDA Enforcement Report
1% Lidocaine HCl Injection, USP, Preservative-Free recalled by Hospira
Hospira is recalling 1% Lidocaine HCl Injection, USP, Preservative-Free, 10 mg/mL Single-dose vials, distributed nationwide in the US. The recall was initiated on 18 Apr 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-0382-2015
- FDA event ID
- 69327
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Apr 2014
- FDA classified
- 30 Jan 2015
- Reported
- 11 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 18 Apr 2014 | Recall initiated by company | |
| 30 Jan 2015 | Classified by FDA | +287 days |
| 11 Feb 2015 | Published in enforcement report | +12 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: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Product as listed by the FDA
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Which lots are affected?
Lot number: 31-427-DK, Exp 01JUL2015.
Where was it sold?
Nationwide.
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.
More recalls from Hospira
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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 Lidocaine recalls
All 119| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalledLidocaine Hydrochloride | Asclemed USA | Sterility | Nationwide |