Taro Recalls Fluocinonide Cream Due to Hydrocortisone Contamination
Taro Pharmaceuticals is recalling specific lots of Fluocinonide Cream 0.05% due to cross-contamination with hydrocortisone-17-valerate.
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 indicates a low probability of adverse health consequences. The hazard involves cross-contamination with a similar corticosteroid, which is a minor labeling/quality error rather than a high-risk pathogen or structural defect.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling 7,776 tubes of Fluocinonide Cream 0.05% (Emulsified Base), packaged in 60 g tubes. The affected product is a prescription-only topical corticosteroid manufactured by Taro Pharmaceuticals Inc. in Brampton, Ontario, Canada, and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, NY.
The recall was initiated because certain lots of the cream were found to be cross-contaminated with a small quantity of hydrocortisone-17-valerate. The specific lots affected are D301311473 and D301411473, both with an expiration date of 3/2017. The product was distributed nationwide in the United States.
Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC 51672-1254-3. If the product matches the recalled description, it should be discontinued and returned to the distributor or disposed of according to local regulations. No specific instructions for patient management are provided in the source text beyond the recall notice.
The recalled product
- Product
- FLUOCINONIDE (FLUOCINONIDE)
- Brand
- FLUOCINONIDE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Topical Corticosteroid
- Affected units
- 7,776
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 #: D301311473
- D301411473
- Exp 3/2017
UPCs (2)
- 0351672126414
- 0351672127923
Distribution
Distributed nationwide across the United States.
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