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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Amneal Pharmaceuticals of New York, LLC
See all →- HighAmneal Recalls Exenatide Injection Pens Due to Potential Empty Delivery System
FDA (Drugs) · 2026-09-30
- HighMethylergonovine Maleate tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-05-08
- SevereVancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling
FDA (Drugs) · 2024-04-24
- HighDivalproex Sodium 250 mg tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-04-03
- ModerateFDA Recalls Oseltamivir Phosphate Oral Suspension for Out-of-Specification Impurities
FDA (Drugs) · 2024-02-28
Same hazard · subpotency
See all →- SeverePfizer Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-10-28
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
Similar recalls
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2014-04-02
- ModerateLyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2018-05-02
- ModerateLyne Laboratories Recalls Subpotent Fluocinolone Acetonide Ear Drops
FDA (Drugs) · 2018-05-02
- LowHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Body Oil
FDA (Drugs) · 2012-08-22
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil
FDA (Drugs) · 2012-08-22
- ModerateTeva Recalls Fluocinolone Acetonide Topical Solution for Impurity and Potency Issues
FDA (Drugs) · 2018-07-18