CLASS II ONGOING Drug recall · Reported 30 Sep 2015 · FDA Enforcement Report
1% Lidocaine HCl Injection, USP, 10 mg/mL Vial recalled by Hospira
Hospira is recalling 1% Lidocaine HCl Injection, USP, 10 mg/mL Vial, Single-dose Preservative Free, distributed nationwide in the US. The recall was initiated on 25 Aug 2015 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-1815-2015
- FDA event ID
- 72072
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Aug 2015
- FDA classified
- 18 Sep 2015
- Reported
- 30 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 25 Aug 2015 | Recall initiated by company | |
| 18 Sep 2015 | Classified by FDA | +24 days |
| 30 Sep 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: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Product as listed by the FDA
1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02
Where it was distributed
Nationwide
Questions about this recall
Is 1% Lidocaine HCl Injection, USP, 10 mg/mL Vial, Single-dose Preservative Free recalled?
Yes. Hospira recalled 1% Lidocaine HCl Injection, USP, 10 mg/mL Vial, Single-dose Preservative Free on 25 Aug 2015. The recall is Class II and its status is Ongoing. Recall number D-1815-2015.
Why was it recalled?
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Which lots are affected?
Lot #: 44-359-DK, Exp 08/01/2016
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 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 Lidocaine recalls
All 46| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Accucaine, Kit contains: Lidocaine HCl Injection recalledAccucaine | Asclemed USA | Sterility | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Huons CoLidocaine Hydrochloride | Huons Co | Sterility | Nationwide |
| Drug | CLASS II | Lidocaine HCl injection, USP, 1% 50mg/ (10 mg/mL) Single Dose Vials recalledLidocaine Hydrochloride | Huons Co | Sterility | Nationwide |
| Drug | CLASS II | LIDOcaine HCl Injection, USP, 10mg/mL recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide |