US Drug Recall Register
Class II · Moderate risk Terminated Initiated Nov 4, 2021 (5 years ago)

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86

Recalling firm
Amneal Pharmaceuticals of New York, LLC
NDC code
65162-703-86
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0234-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.