The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0691-2022·Announced 2022-03-30

Halobetasol Propionate Ointment recalled due to cGMP deviations

Teligent Pharma is recalling all unexpired Halobetasol Propionate Ointment 0.05% (21,323 tubes) due to current good manufacturing practice (cGMP) deviations. The firm 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 stems from cGMP deviations and discontinuation of the stability study program, which is a manufacturing/documentation concern rather than an acute safety threat with demonstrated harm.

Plain-English summary

Teligent Pharma, Inc. is recalling Halobetasol Propionate Ointment, 0.05%, in 50-gram tubes (NDC 63739-998-67) distributed nationwide in the USA and Puerto Rico by McKesson Corporation. The recall affects approximately 21,323 tubes with batch numbers 15720 (expiration 6/30/2022), 16449, and 16450 (expiration 2/28/2023).

The recall is due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program, which prompted the recall of all products within their expiry dates.

Patients using this medication should contact their healthcare provider or pharmacist for guidance. Consumers should not use recalled product and should return it to their pharmacy or disposal location.

The recalled product

Product
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-998-67.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical corticosteroid
Hazard
Affected units
21,323

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 (5)

  • Batch: 15720
  • Exp. 6/30/2022
  • 16449
  • 16450
  • Exp. 2/28/2023

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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