The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0689-2022·Announced 2022-03-30

Halobetasol Propionate Ointment Recalled for cGMP Deviations

Teligent Pharma is recalling all unexpired Halobetasol Propionate Ointment 0.05% due to current Good Manufacturing Practice (cGMP) deviations. The firm has discontinued its 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 for cGMP deviations related to a discontinued stability study program. The source does not report any illnesses, injuries, or adverse events—the hazard is manufacturing-practice noncompliance rather than a direct safety threat. This qualifies as a moderate, precautionary recall.

Plain-English summary

Teligent Pharma, Inc. is recalling Halobetasol Propionate Ointment 0.05% in two package sizes: 15 g tubes (NDC 52565-073-15) and 50 g tubes (NDC 52565-073-51). The recall affects 161,331 tubes distributed nationwide in the USA and Puerto Rico.

The recall is issued due to current Good Manufacturing Practice (cGMP) deviations. The firm has discontinued its stability study program, prompting the recall of all products within expiration dates across multiple batch numbers with expiration dates ranging from 2/28/2022 through 7/31/2023.

Consumers who have this product should stop using it and consult with their healthcare provider or pharmacist regarding their treatment options. Healthcare providers and patients with questions should contact Teligent Pharma or the FDA.

The recalled product

Product
Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical corticosteroid ointment
Hazard
Affected units
161,331

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 (20)

  • Batch: a) 15280
  • Exp. 2/28/2022
  • 16539
  • Exp. 3/31/2023
  • 16907
  • Exp. 5/31/2023
  • b) 15381
  • Exp. 3/31/2022
  • 15382
  • 15501
  • 15523
  • Exp. 4/30/2022
  • 15812
  • Exp. 7/31/2022
  • 15972
  • 16034
  • 16037
  • Exp. 9/30/2022
  • 16105
  • 16143

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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