The Recall Desk
ModerateFDA (Drugs)·D-0670-2022·Announced 2022-03-30

Clobetasol Propionate Cream Recalled Due to cGMP Deviations

Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Cream USP 0.05% nationwide because the manufacturer is discontinuing its stability study program and cannot ensure compliance with current Good Manufacturing Practice standards.

What this means for you

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 based on the agency classification. The recall is precautionary in nature—driven by manufacturing process deviations and discontinuation of stability testing—with no reported illnesses or injuries. The hazard is regulatory non-compliance rather than an acute safety threat.

Plain-English summary

Teligent Pharma, Inc. is recalling Clobetasol Propionate Cream USP, 0.05%, distributed nationwide in the USA and Puerto Rico. The recall affects all products within their expiration dates across four package sizes: 15-gram tubes (NDC 52565-051-15), 30-gram tubes (NDC 52565-051-30), 45-gram tubes (NDC 52565-051-45), and 60-gram tubes (NDC 52565-051-60). A total of 207,933 tubes are being recalled.

The reason for the recall is cGMP (current Good Manufacturing Practice) deviations. Specifically, the firm is discontinuing its stability study program, which is required to demonstrate that the product maintains its safety and effectiveness throughout its shelf life.

Consumers who have this product should stop using it and contact their pharmacy or healthcare provider with questions. Healthcare providers and pharmacies should identify and return the affected product to the manufacturer.

The recalled product

Product
Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical / Corticosteroid
Hazard
  • cgmp-deviation
  • stability-testing-discontinued

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 (19)

  • Batch: a) 15803
  • Exp. 7/31/2022
  • 16237
  • Exp. 11/30/2022
  • b) 15803
  • 16388
  • Exp. 2/28/2023
  • c) 15605
  • d) 15605
  • 15860
  • Exp. 8/31/2022
  • 16001
  • Exp. 9/30/2022
  • 16344
  • Exp. 1/31/2023
  • 16294
  • 16474
  • 16543
  • Exp. 2/28/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

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