Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotency
Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil due to an out-of-specification assay result indicating the drug is subpotent and may not deliver the intended therapeutic dose.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing defect (subpotency) resulting in reduced therapeutic efficacy rather than direct harm, making it a moderate-severity precautionary recall.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Flocinolone Acetonide 0.01% Topical Oil, a prescription medication packaged in 4 oz. bottles. The recall was initiated because an out-of-specification assay result was obtained for Fluocinolone Acetonide, indicating the product is subpotent.
A total of 7,766 bottles have been affected. The recalled product was distributed nationwide within the United States and was packaged under Lot # 07040001A with an expiration date of 02/2022. The NDC number is 65162-704-86.
Patients currently using this medication should consult their healthcare provider regarding their treatment. Subpotent medication may not provide the expected therapeutic benefit.
The recalled product
- 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
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug — Topical Corticosteroid
- Affected units
- 7,766
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 07040001A
- exp. date 02/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Amneal Pharmaceuticals of New York, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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