The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0279-2022·Announced 2021-12-22

Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.

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 involving a manufacturing deviation (CGMP violation) with potential for superpotency. No illnesses or injuries are reported in the source text, and the recall is precautionary in nature to address the facility defect and cracked seals that created the risk.

Plain-English summary

Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) in 50 mL glass bottles. The affected lot was manufactured at the same facility using the same components as products that had cracked seals in caps, which were found to be superpotent.

The recalled product is Lot #16306 with an expiration date of 01/2024. A total of 7,008 glass bottles have been distributed nationwide within the United States. The product carries NDC 63739-997-64.

Consumers who have received this medication should stop use and contact their healthcare provider or pharmacist for guidance. Healthcare professionals and patients should report any adverse events to the FDA's MedWatch program.

The recalled product

Product
LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand
LIDOCAINE HYDROCHLORIDE
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Solution
Hazard
Affected units
7,008

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 #: 16306
  • Exp. Date 01/2024.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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Same brand · LIDOCAINE HYDROCHLORIDE

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Same hazard · superpotency

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