The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0671-2022·Announced 2022-03-30

Clobetasol Propionate Cream USP 0.05% Recall for cGMP Deviations

Teligent Pharma is recalling all unexpired Clobetasol Propionate Cream USP 0.05% nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the firm's stability study program.

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 related to discontinuation of stability studies—a manufacturing/procedural issue rather than a confirmed product defect or contamination. No harm to patients has been reported.

Plain-English summary

Teligent Pharma, Inc. is recalling Clobetasol Propionate Cream USP, 0.05% (Emollient) in four package sizes: 15 grams (NDC 52565-094-15), 30 grams (NDC 52565-094-30), 45 grams (NDC 52565-094-45), and 60 grams (NDC 52565-094-60). A total of 105,200 tubes have been distributed nationwide in the USA and Puerto Rico.

The recall is issued because the manufacturer 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 this recall.

Consumers who have received this medication should contact their pharmacist or healthcare provider before continuing use. Patients should not discontinue use of their medication without consulting their healthcare provider, as abrupt discontinuation could cause harm. The affected batches and expiration dates are listed with the FDA under recall number D-0671-2022.

The recalled product

Product
Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
105,200

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) 15377
  • Exp. 3/31/2022
  • 15927
  • Exp. 9/30/2022
  • 16130
  • Exp. 11/30/2022
  • b) 15117
  • Exp. 2/28/2022
  • 16028
  • 16945
  • Exp. 5/31/2023
  • c) 15377
  • 16683
  • Exp. 5/31/2022
  • d) 15116
  • 15117
  • 16228
  • 16348
  • Exp. 1/31/2023

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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