Galderma Recalls Subpotent Capex Shampoo Due to Low Fluocinolone Acetonide Levels
Galderma is recalling 17,160 bottles of Capex Shampoo because the fluocinolone acetonide content is subpotent. The product was distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. A score of 2 is assigned because the product is subpotent, representing a minor labeling/potency error where the risk of harm is low but not purely cosmetic.
Plain-English summary
Galderma Laboratories, L.P. is recalling 17,160 bottles of Capex Shampoo (fluocinolone acetonide) 0.01%, 4 fl oz in a 6 oz bottle. The recall is due to the product being subpotent, meaning it contains less than the labeled amount of the active ingredient, fluocinolone acetonide.
The affected lots are J090181-H100089, J090181-J100096, and J090181-K100102. The product was distributed nationwide and in Puerto Rico. The shampoo is a prescription-only topical product marketed by Galderma Laboratories, L.P. and manufactured by Hill Dermaceuticals, Inc.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
- Manufacturer
- Galderma Laboratories, L.P.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 17,160
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 (3)
- Lots J090181-H100089
- J090181-J100096
- and J090181-K100102.
Distribution
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