Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only
Recalled by SUN PHARMACEUTICAL INDUSTRIES INC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
SUN PHARMACEUTICAL INDUSTRIES INC has recalled Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 22, 2026 and was initiated on March 25, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, with approximately 2,640 60g tubes affected. The company behind the recall is SUN PHARMACEUTICAL INDUSTRIES INC, based in Princeton, NJ. The FDA describes the product as: “Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.”
Why was Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only recalled?
According to the FDA, the stated reason for the recall is: “Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.”
What should you do?
If you think you may have bought Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, compare it against the product description and identifying codes (Lot# AD76250, Exp Date: 6/30/2026.) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact SUN PHARMACEUTICAL INDUSTRIES INC or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- April 22, 2026
- Recall started
- March 25, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only recalled?+
According to the FDA: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in…
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0477-2026. Information last synced from the FDA on July 6, 2026.