Taro Recalls Desoximetasone Cream Due to Stability Test Failures
Taro Pharmaceuticals is recalling specific lots of Desoximetasone Cream 0.05% because they failed stability specifications for homogeneity.
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: The recall is classified as FDA Class II, and the source text describes a stability specification failure (homogeneity) without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Taro Pharmaceuticals, Inc. is recalling 6,756 units of Desoximetasone Cream USP, 0.05%, 100 g. The affected product is a prescription-only topical corticosteroid manufactured in Brampton, Ontario, Canada, and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, NY. The recall covers lots E0598-19624 and E5099-19624, which have an expiration date of January 2017.
The recall was initiated because the subject lots exhibited out-of-specification (OOS) results for the Homogeneity test, specifically showing moderate separation. This indicates a failure to meet stability specifications for the product's consistency.
The affected units were distributed in the United States and Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or distributor for credit.
The recalled product
- Product
- DESOXIMETASONE (DESOXIMETASONE)
- Brand
- DESOXIMETASONE
- Manufacturer
- Taro Pharmaceuticals, Inc.
- Category
- Drug — Topical Corticosteroid
- Affected units
- 6,756
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)
- Lot #: E0598-19624
- E5099-19624
- Exp. Jan 2017
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Taro Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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