The Recall Desk
HighFDA (Drugs)·D-1053-2022·Announced 2022-06-15

Xylocaine Lidocaine Injectable Anesthetic Recalled for Storage Temperature Abuse

McKesson Medical-Surgical is recalling Xylocaine injectable anesthetic nationwide due to temperature abuse during storage that may compromise medication stability and sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a manufacturing deviation that may have compromised medication stability and sterility. Since no illnesses or injuries are reported in the source, the severity is capped at High per the rubric for Class II recalls without reported harm.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Xylocaine (lidocaine hydrochloride 2% with epinephrine bitartrate) injectable anesthetic vials nationwide. The recall affects multi-dose 20 mL vials distributed in boxes of 25, with approximately 33 boxes recalled in total.

The FDA has classified this as a Class II recall due to temperature abuse, a cGMP deviation. Temperature exposure during storage may have compromised the medication's chemical stability, potency, and the sterility of the multi-dose vial.

Distributors and healthcare providers who received this product have been sent individual recall letters identifying the specific distribution dates for their shipments. Facilities should consult their recall letter and contact McKesson Medical-Surgical for instructions on handling and replacement of affected product.

The recalled product

Product
XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
Brand
XYLOCAINE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable Anesthetic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (14)

  • 0363323484576
  • 0363323485016
  • 0363323483036
  • 0363323487072
  • 0363323486013
  • 0363323495091
  • 0363323488079
  • 0363323489021
  • 0363323495046
  • 0363323491017
  • 0363323492045
  • 0363323492090
  • 0363323482015
  • 0363323481018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 130 products in this recall →

Related recalls

Same brand · XYLOCAINE

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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Same hazard · temperature abuse

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