Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0475-2026·Announced 2026-04-22

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.

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: 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
Hazard: failed-viscosity
out-of-specification
stability-testing
class-ii
prescription-drug

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 →

Same brand · FLUOCINONIDE

Moderate
Taro fluocinonide cream 30 g tubes fail viscosity stability specifications
FDA (Drugs) · 2026-04-22
Moderate
Taro fluocinonide cream 60 g tubes fail viscosity stability specifications
FDA (Drugs) · 2026-04-22
Low
Taro Recalls Fluocinonide Gel Due to Dapsone Cross-Contamination
FDA (Drugs) · 2017-11-01
Moderate
Taro Recalls Fluocinonide Cream Due to Hydrocortisone Contamination
FDA (Drugs) · 2017-05-24

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

See all →

Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
High
Sun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
Low
Fexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08

Same hazard · failed viscosity