The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0704-2022·Announced 2022-03-30

Lidocaine Cream 4% Recalled Due to Manufacturing Quality Deviations

Teligent Pharma is recalling all unexpired batches of Lidocaine Cream 4% (30-gram tubes) nationwide because the company is discontinuing its stability study program, a violation of manufacturing standards.

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/procedural deviation (discontinued stability studies) rather than a confirmed product contamination or defect causing reported illness or injury. The hazard is regulatory/compliance-based rather than an immediate safety threat, making it a Moderate severity recall.

Plain-English summary

Teligent Pharma, Inc. is recalling Lidocaine Cream 4% in 30-gram tubes distributed by RUGBY LABORATORIES (NDC 0536-1281-28). The recall affects approximately 48,907 tubes distributed nationwide in the USA and Puerto Rico. All products within their expiration dates are included, covering batches 15722, 16274, 16947, and 17140, with expiration dates ranging from June 2022 through August 2023.

The recall is due to current Good Manufacturing Practice (cGMP) deviations. Specifically, the firm is discontinuing its stability study program, which is required to ensure drug safety and efficacy over time.

Patients currently using this product should consult their healthcare provider or pharmacist before discontinuing use. Those who have concerns about their specific batch should contact their pharmacy or healthcare provider for guidance.

The recalled product

Product
Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical anesthetic
Hazard
Affected units
48,907

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 (8)

  • Batch: 15722
  • Exp. 6/30/2022
  • 16274
  • Exp. 12/31/2022
  • 16947
  • Exp. 5/31/2023
  • 17140
  • Exp. 8/31/2023

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 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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