The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0674-2022·Announced 2022-03-30

Clobetasol Propionate Gel Recalled Due to Manufacturing Deviations

Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Gel 0.05% due to deviations from good manufacturing practices. The firm discontinued its stability study program, prompting the recall of 81,883 tubes distributed nationwide and in Puerto Rico.

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. The source text indicates a cGMP deviation (discontinuation of stability studies) rather than confirmed product contamination, manufacturing defect, or reported patient harm. The recall is precautionary in nature based on manufacturing practice deviations, without evidence of adverse events.

Plain-English summary

Teligent Pharma, Inc. is recalling Clobetasol Propionate Gel 0.05% in three package sizes: 15-gram tubes (NDC 52565-082-15), 30-gram tubes (NDC 52565-082-30), and 60-gram tubes (NDC 52565-082-60). A total of 81,883 tubes are affected.

The recall was initiated because the firm is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practice (cGMP) requirements. All products within their expiration dates are included in the recall.

The affected product has been distributed nationwide in the United States and in Puerto Rico. Specific batch numbers and expiration dates are listed in the agency documentation.

Patients who have been prescribed this medication should contact their healthcare provider or pharmacist for guidance on alternative treatments or verification of whether their specific batch is affected.

The recalled product

Product
Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
81,883

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 (16)

  • Batch: a) 15063
  • Exp. 2/28/2022
  • 15928
  • Exp. 9/30/2022
  • 16432
  • Exp. 2/28/2023
  • 16769
  • Exp. 4/30/2023
  • b) 15243
  • 16628
  • Exp. 3/31/2023
  • c) 15064
  • 15286
  • 15287
  • 16173
  • Exp. 11/30/2022

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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