Betamethasone Dipropionate Lotion recalled for failed stability test
Teligent Pharma is recalling Betamethasone Dipropionate Lotion USP 0.05% (Augmented) due to failure to meet specification for the Active Pharmaceutical Ingredient particle test during routine stability testing.
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. The source text does not report any illnesses, injuries, or deaths. The hazard is a failed specification test—a quality/stability issue without documented patient harm, which fits the Moderate category for precautionary pharmaceutical recalls.
Plain-English summary
Teligent Pharma, Inc. is recalling Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottles. This is a prescription corticosteroid lotion distributed nationwide in the USA.
The recall was initiated because lot 16569 failed to meet specification for the Active Pharmaceutical Ingredient (API) particle test during routine stability testing.
Consumers who have received this product should consult their healthcare provider or pharmacist for guidance. The affected lot number is 16569 with an expiration date of 9/2022.
The recalled product
- Product
- Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Affected units
- 3,792
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 (2)
- Lot # 16569
- Exp 9/2022
Distribution
Distributed nationwide across the United States.
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