Clobetasol Propionate Cream recalled due to subpotent drug
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% nationwide because stability testing revealed insufficient active ingredient in the affected lot.
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: FDA Class III recall with no reported illnesses or injuries. The hazard is subpotency (insufficient active pharmaceutical ingredient), which affects drug efficacy but does not pose direct immediate safety risk.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Clobetasol Propionate Cream USP, 0.05%, 45 gram tubes nationwide. The product is a prescription topical corticosteroid.
The recall was initiated because long-term stability testing revealed a low assay result, indicating that the drug is subpotent—containing less active ingredient than specified on the label. Approximately 5,720 tubes with lot number K101033 (expiration date June 2024) were distributed nationwide.
If you have received this medication with the affected lot number, contact your pharmacy or healthcare provider. Do not use the product. Return it to the pharmacy for proper disposal or replacement with a properly potent product.
The recalled product
- Product
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
- Brand
- CLOBETASOL PROPIONATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- subpotent
- low-assay
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#: K101033
- Exp 6/2024
Distribution
Distributed nationwide across the United States.
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