FDA Drug recall D-0233-2022
Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 088…
- FDA Drug
- Class II
- terminated
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 088… by Amneal Pharmaceuticals, citing subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0233-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-04 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Identifiers
| code_info | Lot #: 07040001A, exp. date 02/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0233-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.