The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1047-2022·Announced 2022-06-15

FDA recalls Lidocaine-Prilocaine topical anesthetic cream for temperature abuse

McKesson Medical-Surgical is recalling Lidocaine and Prilocaine Cream due to cGMP deviations involving temperature abuse during distribution. The recall affects 23 tubes distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a cGMP deviation related to temperature abuse during distribution—a precautionary manufacturing issue without evidence of actual product failure or patient harm.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Lidocaine and Prilocaine Cream, 2.5%/2.5%, in 5-gram tubes (NDC 0168-0357-56) distributed nationwide. The recall involves 23 tubes that were distributed in the United States.

The reason for the recall is a cGMP (current Good Manufacturing Practice) deviation related to temperature abuse during storage and distribution of the product. The specific nature of the risk posed by this temperature exposure is not detailed in the available recall information.

McKesson was unable to identify the specific lot numbers for individual consignees. Customers were notified individually with the dates when product was distributed to them and the dates when impacted product may have been shipped.

The recalled product

Product
LIDOCAINE AND PRILOCAINE (LIDOCAINE AND PRILOCAINE)
Brand
LIDOCAINE AND PRILOCAINE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Topical Anesthetic
Hazard
Affected units
23

Is your product affected?

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

UPCs (1)

  • 0301680357300

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 →

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