Taro fluocinonide cream 30 g tubes fail viscosity stability specifications
Taro is recalling one lot of Fluocinonide 0.05% Cream in 30 g tubes after stability testing returned viscosity results above the specification limit. 41,712 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 30 g tubes, NDC 51672-1386-2. The product is manufactured in Brampton, Ontario and distributed by Taro Pharmaceuticals U.S.A., Inc. The action covers 41,712 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 AD76251, 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# AD76251
- 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
Same brand · FLUOCINONIDE
- ModerateTaro fluocinonide cream recalled for out-of-specification viscosity during stability testing
FDA (Drugs) · 2026-04-22
- ModerateTaro fluocinonide cream 60 g tubes fail viscosity stability specifications
FDA (Drugs) · 2026-04-22
- LowTaro Recalls Fluocinonide Gel Due to Dapsone Cross-Contamination
FDA (Drugs) · 2017-11-01
- ModerateTaro Recalls Fluocinonide Cream Due to Hydrocortisone Contamination
FDA (Drugs) · 2017-05-24
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · failed viscosity
See all →- ModerateVertra Sunscreen Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2017-12-06