The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0694-2022·Announced 2022-03-30

Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations

Teligent Pharma, Inc. is recalling all unexpired batches of Lidocaine Ointment USP, 5% nationwide and in Puerto Rico because the manufacturer is discontinuing its stability study program, a violation of good manufacturing practices.

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-practice deviation. The source text does not report any illnesses, injuries, or deaths. The recall is based on a procedural/regulatory violation (discontinuation of stability studies) rather than confirmed product defect or contamination, making it a precautionary recall.

Plain-English summary

Teligent Pharma, Inc. is recalling Lidocaine Ointment USP, 5% (35.44 g/1¼ oz tubes, NDC 52565-008-14) distributed nationwide in the USA and Puerto Rico. The recall affects all products within expiry, including Batch 16389 (Exp. 2/29/2024) and Batch 16452 (Exp. 2/29/2024).

The recall has been issued because Teligent Pharma is discontinuing its stability study program. This action constitutes a deviation from current Good Manufacturing Practice (cGMP) requirements for pharmaceutical products.

Consumers who have this lidocaine ointment should stop using it and consult their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacies should quarantine affected stock and contact their suppliers for return instructions.

The recalled product

Product
Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Pharmaceutical / Anesthetic
Hazard
Affected units
100,256

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 (3)

  • Batch: 16389
  • Exp. 2/29/2024
  • 16452

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 37 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 37 products in this recall →

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