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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

Fresenius Kabi USA LLC: Xylocaine-MPF with Epinephrine Recalled for Low Epinephrine Levels

Agency Publication Date: July 7, 2021
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Summary

Fresenius Kabi USA LLC is recalling approximately 234,800 vials of Xylocaine-MPF with Epinephrine 1:200,000 (Lidocaine HCl and Epinephrine Injection, USP), 1%, in 30 mL single-dose vials. The recall was initiated because laboratory testing revealed lower-than-required levels of epinephrine in certain batches. This product is typically used as a local anesthetic for surgical procedures, and if the epinephrine levels are too low, the medication may not work as intended. Consumers and healthcare providers should check for specific lot numbers and contact their pharmacist or healthcare provider for guidance on returning the product for a refund.

Risk

Epinephrine is added to lidocaine to help control bleeding and to make the anesthetic effect last longer by narrowing blood vessels. If levels are lower than specified, the medication may wear off too quickly or fail to control local bleeding during a medical procedure, potentially requiring additional medical intervention.

What You Should Do

  1. Check your medical supplies for Xylocaine-MPF with Epinephrine 1:200,000 (Lidocaine HCl and Epinephrine Injection, USP), 1% in 30 mL Single Dose Vials.
  2. Identify if your product is affected by looking for Batch 6123435 (Expiration 01/2022), or Batches 6124730 and 6124731 (Expiration 07/2022).
  3. Verify the NDC numbers located on the packaging: Vial NDC 63323-487-07 or Tray NDC 63323-487-37.
  4. If you have an affected lot, contact your healthcare provider or pharmacist immediately for guidance and do not use the vials.
  5. Return any unused vials to the pharmacy or medical facility where they were purchased to receive a refund.
  6. For further questions or to report issues, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider or pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial
Model:
Vial NDC 63323-487-07
Tray NDC 63323-487-37
Lot Numbers:
Batch 6123435 (Exp 01/2022)
Batch 6124730 (Exp 07/2022)
Batch 6124731 (Exp 07/2022)
Date Ranges: Exp 01/2022, Exp 07/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88194
Status: Resolved
Manufacturer: Fresenius Kabi USA LLC
Sold By: Hospitals; Medical Clinics; Pharmacies
Manufactured In: United States
Units Affected: 234,800 vials
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.