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.
What this means for you
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
- cgmp-deviation
- stability-study-discontinuation
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.
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