Taro fluocinonide cream recalled for out-of-specification viscosity during stability testing
Taro is recalling one lot of Fluocinonide 0.05% Cream after stability testing returned out-of-specification viscosity results above the specification limit. 24,672 tubes are affected.
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: FDA Class II recall for a physical property outside specification, with no potency, purity or contamination failure described, which fits the Moderate band.
Plain-English summary
Taro Pharmaceuticals is recalling Fluocinonide, USP, 0.05% Cream, in 15 g tubes, NDC 51672-1386-1. The product is manufactured in Brampton, Ontario and distributed by Taro Pharmaceuticals U.S.A., Inc. The action covers 24,672 tubes.
The stated reason is failed viscosity specifications: out-of-specification results above the specification limit were noted in viscosity during stability testing. Viscosity is a physical property of the cream base. The FDA classified the action as Class II. The source does not describe any failure of potency, purity or sterility.
The affected lot is AD76252, expiry 6/30/2026. Distribution was nationwide in the USA.
This is a prescription medicine. Patients should not stop a prescribed treatment without medical advice; anyone holding the affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- FLUOCINONIDE (FLUOCINONIDE)
- Brand
- FLUOCINONIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Topical corticosteroid
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# AD76252
- Exp Date: 6/30/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by SUN PHARMACEUTICAL INDUSTRIES 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 3 products in this recall →Related recalls
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