Lupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% because it failed content uniformity specifications. The recall covers 5,082 tubes distributed nationwide.
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: The recall is classified as FDA Class II due to failed content uniformity specifications, which is a quality control issue that may lead to variable dosing but is not associated with reported serious injuries or deaths in the source text.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Clobetasol Propionate Cream USP, 0.05%, 60 g tube. The recall was initiated because the product failed content uniformity specifications. The affected product is a prescription-only topical medication manufactured for Lupin Pharmaceuticals, Inc., in Naples, FL, and manufactured by Lupin Limited in India.
The recall involves 5,082 tubes of the medication. The affected lots are KB00427 (expiration date 4/30/2028) and KA00308 (expiration date 10/31/2026). The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
- Brand
- CLOBETASOL PROPIONATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 5,082
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)
- Lot#: KB00427
- Exp date 4/30/2028
- KA00308
- Exp date 10/31/2026
Distribution
Distributed nationwide across the United States.
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