The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0690-2022·Announced 2022-03-30

Hydrocortisone Butyrate Lotion recalled due to cGMP deviations

Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% (4 fl. oz. bottles) nationwide because the manufacturer discontinued its stability study program, which is a deviation from good manufacturing practice standards.

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 cGMP deviation related to discontinued stability testing—a procedural/manufacturing defect rather than a direct safety threat. No hospitalization or serious injury reports are mentioned, and the source text does not indicate active product harm, making this a precautionary manufacturing-related recall.

Plain-English summary

Teligent Pharma, Inc. is recalling Hydrocortisone Butyrate Lotion 0.1%, supplied in 4 fl. oz. (118 mL) bottles (NDC 51862-159-04) and distributed by Mayne Pharma in Greenville, NC. The recall affects approximately 6,431 bottles distributed nationwide in the USA and Puerto Rico.

The recall was initiated because Teligent Pharma discontinued its stability study program. This discontinuation constitutes a deviation from current good manufacturing practice (cGMP) standards. All products within expiration dates are included in the recall.

Affected batch numbers are 15435 (expiration 3/31/2022) and 16960 (expiration 5/31/2023). Consumers who have this product should contact their healthcare provider or pharmacist for guidance. The product is prescription-only and should be returned to the pharmacy where it was dispensed.

The recalled product

Product
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
6,431

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 (4)

  • Batch: 15435
  • Exp. 3/31/2022
  • 16960
  • Exp. 5/31/2023

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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