Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotent Drug
Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil because testing found out-of-specification assay results, meaning the drug may contain less active ingredient than labeled.
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. The source states no illnesses or injuries have been reported. Subpotency (reduced active ingredient) is a pharmaceutical quality issue rather than a contamination or acute safety hazard, making it a moderate precautionary recall.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Flocinolone Acetonide 0.01% Topical Oil (Scalp Oil), packaged in 4 oz. bottles and distributed nationwide in the United States. The recall was initiated because out-of-specification assay results were obtained for Flocinolone Acetonide, indicating the product may be subpotent.
Affected product: NDC 65162-703-86, Lot #07030002A, expiration date 02/2022. Approximately 15,880 bottles were distributed. The product is a prescription medication used as a topical oil.
Patients who have this medication should consult their healthcare provider about whether to continue using it or obtain replacement product. Healthcare providers and patients should report adverse events to the FDA's MedWatch program or call Amneal Pharmaceuticals directly.
The recalled product
- Product
- Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug — Topical / Prescription
- Affected units
- 1,588
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 #: 07030002A
- 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 · subpotent drug
See all →- SeverePfizer Recalls Levoxyl Tablets Due to Subpotent Drug Levels
FDA (Drugs) · 2026-10-28
- LowImprimisRx Recalls Subpotent Povidone Iodine and Proparacaine Ophthalmic Solution
FDA (Drugs) · 2026-09-16
- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
Similar recalls
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2014-04-02
- HighLyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2018-05-02
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil
FDA (Drugs) · 2012-08-22
- 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
- LowHill Dermaceuticals Recalls Subpotent DermOtic Oil Ear Drops
FDA (Drugs) · 2014-04-02