The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0672-2022·Announced 2022-03-30

Clobetasol Propionate Lotion recall due to manufacturing deviations

Teligent Pharma is recalling 35,180 bottles of Clobetasol Propionate Lotion 0.05% nationwide due to manufacturing deviations and discontinued stability testing. No illnesses reported.

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 a Class II voluntary precautionary recall with no reported illnesses or injuries. The recall stems from manufacturing deviations and discontinued stability testing rather than a confirmed hazard. Per the severity rubric, voluntary precautionary recalls are classified as Moderate.

Plain-English summary

Teligent Pharma, Inc. is recalling Clobetasol Propionate Lotion, 0.05%, in 2 fl. oz. (59 mL) and 4 fl. oz. (118 mL) bottles, totaling 35,180 units. The affected products were distributed nationwide in the USA and Puerto Rico.

The recall is due to current Good Manufacturing Practice (cGMP) deviations identified at the manufacturing facility. The firm is also discontinuing its stability study program, meaning it can no longer verify the product maintains its intended safety and effectiveness throughout its shelf life.

Consumers with this medication should contact their healthcare provider or pharmacist for guidance. Do not discontinue use without medical advice, as sudden cessation of prescribed topical corticosteroids may cause adverse effects.

The recalled product

Product
Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
35,180

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 (18)

  • Batch: a) 15599
  • Exp. 4/30/2022
  • 16108
  • Exp. 10/31/2022
  • 16471
  • Exp. 2/28/2023
  • 16680
  • Exp. 3/31/2023
  • b) 15120
  • 15126
  • 15592
  • Exp. 2/28/2022
  • 15599
  • 16145
  • 16261
  • Exp. 12/31/2022
  • 16456
  • 16552

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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