Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Flocinolone Acetonide 0.01% Topical Oil Recalled by Amneal Pharmaceuticals of New York, LLC Due to Subpotent Drug: Out-of-specification assay result was obtained for...

Date: November 4, 2021
Company: Amneal Pharmaceuticals of New York, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amneal Pharmaceuticals of New York, LLC directly.

Affected Products

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86

Quantity: 7,766 bottles

Why Was This Recalled?

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Amneal Pharmaceuticals of New York, LLC

Amneal Pharmaceuticals of New York, LLC has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report