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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lidocaine HCl Injection Recalled for Lack of Assurance of Sterility

Agency Publication Date: September 30, 2024
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Summary

Fagron Compounding Services is recalling several lots of Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) pre-filled syringes. This prescription medication is used as a local anesthetic to numb a specific area of the body during medical procedures. The recall was issued because the company cannot guarantee that the product is sterile, which is a critical safety requirement for injectable drugs.

Risk

Injecting a drug that is not sterile can introduce bacteria or other contaminants directly into a patient's body. This poses a significant risk of serious or life-threatening infections at the injection site or in the bloodstream, particularly for patients who are already ill or have weakened immune systems.

What You Should Do

  1. This recall affects Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, labeled as Fagron Sterile Services (Wichita, KS).
  2. Check your medical supplies for syringes with the following lot numbers: C274-000037397, C274-000037398, C274-000037399, or C274-000037400. All affected syringes have an expiration date of 10/14/2024.
  3. Stop using the recalled product immediately.
  4. Contact Fagron Compounding Services or your medical distributor to arrange for the return of any remaining affected stock.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringeby Fagron Sterile Services
Variants: 2%, 20mg per mL, 100 mg per 5 mL
Lot Numbers:
C274-000037397 (Exp 10/14/2024)
C274-000037398 (Exp 10/14/2024)
C274-000037399 (Exp 10/14/2024)
C274-000037400 (Exp 10/14/2024)

Rx only; Manufactured by Fagron Compounding Services/Fagron Sterile Services at 8710 E. 34th St, N. Wichita, KS 67226.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95146
Status: Active
Manufacturer: Fagron Compounding Services
Sold By: Hospitals; Clinics; Wholesalers; Medical distributors
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.