The Recall Desk
ModerateFDA (Drugs)·D-0673-2022·Announced 2022-03-30

Clobetasol Propionate Ointment USP 0.05% Nationwide Recall

Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Ointment USP 0.05% nationwide because the manufacturer is discontinuing its stability study program, raising questions about product integrity.

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 involving a cGMP deviation (discontinuation of stability testing). No illnesses, injuries, or deaths are reported. The hazard is manufacturing-process-related rather than an acute safety threat, warranting a Moderate classification consistent with precautionary Class II recalls.

Plain-English summary

Teligent Pharma, Inc. is recalling Clobetasol Propionate Ointment USP 0.05% in four package sizes: 15 grams (NDC 52565-039-15), 30 grams (NDC 52565-039-30), 45 grams (NDC 52565-039-45), and 60 grams (NDC 52565-039-60). A total of 72,826 tubes are affected.

The recall affects all products within expiry and applies nationwide in the USA and Puerto Rico. The recall was initiated because the firm is discontinuing its stability study program, which represents a deviation from current Good Manufacturing Practice (cGMP) requirements.

Affected batches include: 15g tubes (batch 15856, exp. 8/31/2022; batch 17026, exp. 6/30/2023); 30g tubes (batch 15856, exp. 8/31/2022; batch 17026, exp. 6/30/2023; batch 17046, exp. 6/30/2023); 45g tubes (batch 15856, exp. 8/31/2022); and 60g tubes (batch 15856, exp. 8/31/2022; batch 17026, exp. 6/30/2023).

Consumers and healthcare providers should discontinue use of the affected product. Patients taking this prescription ointment should contact their healthcare provider for guidance on alternative treatments.

The recalled product

Product
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, 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 (8)

  • Batch: a) 15856
  • Exp. 8/31/2022
  • 17026
  • Exp. 6/30/2023
  • b) 15856
  • 17046
  • c) 15856
  • d) 15856

Distribution

Distributed nationwide across the United States.

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