CLASS II Drug recall · Reported 26 Dec 2012 · FDA Enforcement Report
Lidocaine HCl Injection, USP, 1% (10 mg/mL) Single-dose Teartop Vial recalled
Hospira is recalling Lidocaine HCl Injection, USP, 1% (10 mg/mL) Single-dose Teartop Vial, distributed nationwide in the US. The recall was initiated on 4 Oct 2012 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-099-2013
- FDA event ID
- 63913
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Oct 2012
- FDA classified
- 20 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 4 Oct 2012 | Recall initiated by company | |
| 20 Dec 2012 | Classified by FDA | +77 days |
| 26 Dec 2012 | Published in enforcement report | +6 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: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Product as listed by the FDA
Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.
Where it was distributed
Nationwide
Questions about this recall
Is Lidocaine HCl Injection, USP, 1% (10 mg/mL) Single-dose Teartop Vial recalled?
Yes. Hospira recalled Lidocaine HCl Injection, USP, 1% (10 mg/mL) Single-dose Teartop Vial on 4 Oct 2012. The recall is Class II and its status is Terminated. Recall number D-099-2013.
Why was it recalled?
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Which lots are affected?
Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01
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 |