Amneal recalls 4 oz. Flocinolone Acetonide 0.01% Topical Oil due to subpotent drug levels. This may not provide intended treatment. Consumers should contact Amneal for details.
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Amneal is recalling a specific 4 oz. topical oil for scalp use because lab tests showed it contains less active ingredient than it should. This means the product might not work as intended for treating conditions like psoriasis or eczema.
The lab test found the product has lower levels of the active drug than it should. This means it may not treat skin conditions effectively. However, the product does not cause immediate harm or injury.
People who have the 4 oz. bottle of Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, with lot number 07030002A, manufactured by Amneal Pharmaceuticals. Those using this product for scalp conditions are most at risk.
Check for the 4 oz. bottle labeled 'Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx' with lot number 07030002A. This product was distributed by Amneal Pharmaceuticals and expired February 2022.
Look for the lot number 07030002A on the bottle to confirm if it's recalled.
No, the product is not dangerous but may not work as intended due to lower drug levels.
Contact Amneal Pharmaceuticals for instructions on what to do with the product.
The recall is for subpotent drug levels, not a risk of serious injury.
We’ve drafted a message you can send Amneal to request your refund or repair — edit it as you like.
Subject: Recall D-0234-2022 — Amneal Amneal Hello, I own a Amneal that is covered by recall D-0234-2022 from Amneal. 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.
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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.
