The Recall Desk
ModerateFDA (Drugs)·D-0116-2017·Announced 2016-11-09

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.

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 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
Hazard
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

Same manufacturer · Taro Pharmaceuticals, Inc.

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Same hazard · stability failure

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