Amneal Pharmaceuticals recalls 4 oz. Flocinolone Acetonide 0.01% Topical Oil due to subpotent drug levels. This may not provide intended treatment. Check NDC 65162-704-86 and lot 07040001A for affected products.
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Amneal Pharmaceuticals is recalling a 4 oz. topical steroid cream that may have lower-than-stated drug levels. This could mean the product doesn't work as intended for skin conditions. People using this medication should check if they have the specific lot number and NDC code listed.
The product was tested and found to have lower-than-stated levels of the active drug. This means it might not treat skin conditions effectively. However, it does not pose a risk of serious injury or harm.
People with prescription skin conditions who use this specific topical steroid cream. Those with the NDC code 65162-704-86 and lot number 07040001A are most at risk.
Check for the 4 oz. bottle labeled 'Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx'. Look for NDC code 65162-704-86 and lot number 07040001A on the packaging.
Look for the NDC code 65162-704-86 and lot number 07040001A on the product label.
No, this product does not pose a risk of serious injury or harm. It may not work as intended due to lower-than-stated drug levels.
Check the product label for the NDC code 65162-704-86 and lot number 07040001A. If you have these details, contact Amneal Pharmaceuticals for further instructions.
The affected product has the NDC code 65162-704-86 and lot number 07040001A. Check the label on your bottle.
We’ve drafted a message you can send Amneal Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0233-2022 — Amneal Pharmaceuticals Amneal Pharmaceuticals Hello, I own a Amneal Pharmaceuticals that is covered by recall D-0233-2022 from Amneal Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
