The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0688-2022·Announced 2022-03-30

Halobetasol Propionate Ointment Recalled for cGMP Deviations

Teligent Pharma is recalling all unexpired batches of Halobetasol Propionate Ointment 0.05% nationwide due to cGMP deviations. The manufacturer is discontinuing 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 with no reported illnesses or injuries. The hazard is procedural—discontinuation of stability testing—rather than a detected contamination or defect. No actual harm has been reported.

Plain-English summary

Teligent Pharma, Inc. is recalling 35,185 tubes of Halobetasol Propionate Ointment 0.05% (50-gram tubes, NDC 70512-033-50) manufactured for SOLA Pharmaceuticals due to current good manufacturing practice (cGMP) deviations. The recall affects all products within expiry date.

The reason for the recall is that the firm is discontinuing its stability study program. Affected batches include: Batch 15128 (Exp. 2/28/2022), Batch 15721 (Exp. 6/30/2022), Batch 16171 (Exp. 10/31/2022), Batch 16819 (Exp. 4/30/2023), and Batch 17124 (Exp. 7/31/2023).

The product has been distributed nationwide in the USA and Puerto Rico. Consumers who have obtained this product should consult their healthcare provider or pharmacist regarding safe alternatives.

The recalled product

Product
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
35,185

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 (10)

  • Batch: 15128
  • Exp. 2/28/2022
  • 15721
  • Exp. 6/30/2022
  • 16171
  • Exp. 10/31/2022
  • 16819
  • Exp. 4/30/2023
  • 17124
  • Exp. 7/31/2023

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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