Flocinolone Acetonide 0 — Class II drug recall D-0233-2022
Terminated recall by Amneal Pharmaceuticals of New York, LLC, reported 2021-11-24, distributed nationwide. Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
| Recall number | D-0233-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY, United States |
| Recall initiated | 2021-11-04 |
| Classified | 2021-11-16 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2022-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 7,766 bottles |
| Reason classes | potency |
| NDC | 65162-0704-86 |
| Lot numbers | 07040001A |
| Expiration dates | 2022-02 |
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 for recall
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0233-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.