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.
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. 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
- Hazard
- subpotent-drug
- out-of-specification-assay
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27