Taro Recalls Clobetasol Propionate Cream Due to Content Uniformity Failure
Taro Pharmaceuticals is recalling specific lots of Clobetasol Propionate Cream 0.05% because the bulk material failed content uniformity testing.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a quality control failure (content uniformity) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling specific lots of Clobetasol Propionate Cream USP, 0.05%, in 15 g and 45 g tubes. The recall involves 7,632 tubes distributed nationwide in the United States. The affected products are identified by lot codes AB28353 and AB40178, both with an expiration date of 12/31/2021.
The recall was initiated because the bulk lot used to manufacture these specific product lots was found to have failed content uniformity testing. This means the concentration of the active ingredient may not be consistent throughout the product.
Consumers who have these specific lots of Clobetasol Propionate Cream should stop using the product and contact their healthcare provider or pharmacist for guidance. The product is marketed by Golden State Medical Supply, Inc.
The recalled product
- Product
- Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. C
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 7,632
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)
- a) AB28353
- Exp 12/31/2021
- b) AB40178
Distribution
Distributed nationwide across the United States.
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