CLASS I Drug recall · Reported 15 Nov 2023 · FDA Enforcement Report
1% Lidocaine HCl Injection, USP, 50mg/(10mg/mL) recalled by Pfizer
Pfizer is recalling 1% Lidocaine HCl Injection, USP, 50mg/(10mg/mL), distributed nationwide in the US. The recall was initiated on 2 Oct 2023 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-0101-2024
- FDA event ID
- 93124
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Oct 2023
- FDA classified
- 9 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 2 Oct 2023 | Recall initiated by company | |
| 9 Nov 2023 | Classified by FDA | +38 days |
| 15 Nov 2023 | 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: identified as glass.
Product as listed by the FDA
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11
Where it was distributed
Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: identified as glass.
Which lots are affected?
Lot#: 42290DK, Exp. 6/1/2024
Where was it sold?
Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
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.
Other products in this recall event
2 other products · FDA event 93124This product is part of a recall event; the main page for the event is 2% Lidocaine HCl Injection, USP, 100mg/(20mg/mL) recalled by Pfizer.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | 2% Lidocaine HCl Injection, USP, 100mg/(20mg/mL) recalled by Pfizer | Pfizer | Particulate Matter | Nationwide | |
| CLASS I | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5mEq/mL) recalled | Pfizer | Particulate Matter | Nationwide |
More recalls from Pfizer
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Lidocaine recalls
All 120| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine Ointment USP, 5%, Speermint Flavor recalledLidocaine | SUN Pharma /Taro | Potency & Assay | Nationwide |
| 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 |