Taro Recalls Fluocinonide Gel Due to Dapsone Cross-Contamination
Taro Pharmaceuticals is recalling 16,944 tubes of Fluocinonide Gel USP 0.05% because traces of Dapsone were found in the finished product.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling 16,944 tubes of Fluocinonide Gel USP, 0.05%, 15 g tube. The 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 specific lot affected is A771026850, with an expiration date of 6/18.
The recall was initiated due to cross-contamination with other products, specifically the presence of traces of Dapsone in the finished product. The agency has classified this recall as Class III, indicating that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations for prescription medications.
The recalled product
- Product
- FLUOCINONIDE (FLUOCINONIDE)
- Brand
- FLUOCINONIDE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Topical Corticosteroid
- Affected units
- 16,944
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 (2)
- Lot #: A771026850
- Exp 6/18
UPCs (2)
- 0351672126414
- 0351672127923
Distribution
Distributed nationwide across the United States.
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