The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0675-2022·Announced 2022-03-30

Desonide Ointment Recalled Due to cGMP Deviations

Teligent Pharma is recalling all unexpired batches of Desonide Ointment 0.05% nationwide because the manufacturer is discontinuing its stability study program, a deviation from current good manufacturing practices (cGMP).

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 manufacturing practice deviation rather than a documented contamination or defect, making this a precautionary recall appropriate for a Moderate severity rating.

Plain-English summary

Teligent Pharma, Inc. is recalling Desonide Ointment 0.05% in two package sizes: 15 gram tubes (NDC 52565-038-15) and 60 gram tubes (NDC 52565-038-60). The recall includes 36,426 tubes distributed nationwide in the USA and Puerto Rico.

The recall is issued because the firm is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practices (cGMP). All products within their expiration dates are affected.

Consumers who have received this medication should contact their healthcare provider or pharmacist for guidance. The affected batches and expiration dates are: 15 g tubes (batches 15495 [exp. 4/30/2022], 16955 [exp. 5/31/2023]); 60 g tubes (batches 15249, 15250, 15446 [exp. 3/31/2022], 15495 [exp. 4/30/2022], 16377 [exp. 1/31/2023]).

The recalled product

Product
Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
36,426

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 (11)

  • Batch: a) 15495
  • Exp. 4/30/2022
  • 16955
  • Exp. 5/31/2023
  • b) 15249
  • 15250
  • 15446
  • Exp. 3/31/2022
  • 15495
  • 16377
  • 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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