Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0296-2022·Announced 2022-01-05

Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to superpotency. The affected lot was 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. Superpotency in a topical anesthetic represents a manufacturing deviation that could affect efficacy or safety, but without evidence of actual harm, it falls under moderate severity precautionary recalls.

Plain-English summary

Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles. The product is a prescription topical anesthetic manufactured by Teligent Pharma, Inc. in Buena, NJ, and distributed by McKesson Corporation dba Sky Packaging. The recall affects 7,176 bottles of lot #15594 with an expiration date of 05/2023.

The product is being recalled due to superpotency. The affected lot was distributed to a wholesaler in Colorado, who further distributed it nationwide in the USA.

Consumers and healthcare providers who have received this product should stop use and contact their healthcare provider with any questions or concerns. The NDC number for the recalled product is 63739-997-64.

The recalled product

Product: LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand: LIDOCAINE HYDROCHLORIDE
Manufacturer: Teligent Pharma, Inc.
Category: Drug — Topical Anesthetic
Hazard: superpotency
Affected units: 7,176

Is your product affected?

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

Lot numbers (2)

Lot #: 15594
Exp Date 05/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Teligent Pharma, Inc. 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 2 products in this recall →

Same brand · LIDOCAINE HYDROCHLORIDE

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Same hazard · superpotency