Taro Recalls Desoximetasone Cream Due to Failed Stability Specifications
Taro Pharmaceuticals is recalling specific lots of Desoximetasone Cream 0.25% because they failed stability tests for moderate separation.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific defect is a stability failure (moderate separation) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or quality issues.
Plain-English summary
Taro Pharmaceuticals, Inc. is recalling 15,576 units of Desoximetasone Cream USP, 0.25%, 100 g, prescription only. The affected product is distributed in the US and Puerto Rico. The recall involves specific lots with expiration dates in January and February 2017.
The recall was initiated because the subject lots exhibited Out-of-Specification (OOS) results for the Homogeneity test, specifically indicating moderate separation. This is a quality control issue related to the physical stability of the cream.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for credit or replacement.
The recalled product
- Product
- DESOXIMETASONE (DESOXIMETASONE)
- Brand
- DESOXIMETASONE
- Manufacturer
- Taro Pharmaceuticals, Inc.
- Category
- Drug — Topical Corticosteroid
- Affected units
- 15,576
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 (7)
- Lot #: B5093-18608
- B5094-18608
- Exp. Jan 2017
- Lot #: C5141-18954
- C5142-18954
- E5109-19625
- Exp . Feb 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
Same brand · DESOXIMETASONE
- ModerateTaro Recalls Desoximetasone Cream Due to Stability Test Failures
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