The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0705-2022·Announced 2022-03-30

Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations

Teligent Pharma, Inc. is recalling Lidocaine Ointment USP 5% nationwide because the manufacturer is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practice (cGMP). All products within their expiration dates are affected.

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 (manufacturing practice deficiency) rather than a direct safety or efficacy threat. The source text does not report any adverse health events or patient harm, making this a precautionary recall based on regulatory non-compliance.

Plain-English summary

Teligent Pharma, Inc. is recalling Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tubes manufactured for Hi-Tech Pharmacal Co., Inc. The recall applies to Batch 16695 with expiration date 4/30/2024. All products within their expiration dates are included in the recall.

The recall was initiated because the firm is discontinuing its stability study program, which represents a deviation from current good manufacturing practice (cGMP) standards required by the FDA for pharmaceutical manufacturing.

The product was distributed nationwide in the USA and Puerto Rico. Approximately 49,081 tubes are affected. The product is prescription only (Rx Only) and bears NDC 50383-341-35.

Consumers and healthcare providers who have this product should stop using it and consult with their pharmacist or healthcare provider about alternatives. Patients should not stop taking prescribed medication without medical guidance.

The recalled product

Product
Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical / Local Anesthetic
Hazard
Affected units
49,081

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)

  • Batch: 16695
  • Exp 4/30/2024

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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