CLASS II Drug recall · Reported 24 Nov 2021 · FDA Enforcement Report
Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx recalled
Amneal Pharmaceuticals of New York is recalling Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, distributed nationwide in the US. The recall was initiated on 4 Nov 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0234-2022
- FDA event ID
- 88997
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2021
- FDA classified
- 16 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 4 Nov 2021 | Recall initiated by company | |
| 16 Nov 2021 | Classified by FDA | +12 days |
| 24 Nov 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Product was distributed nationwide within the United States
Questions about this recall
Why was it recalled?
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Which lots are affected?
Lot #: 07030002A, exp. date 02/2022
Where was it sold?
Product was distributed nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88997This product is part of a recall event; the main page for the event is Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
More recalls from Amneal Pharmaceuticals of New York
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Flocinolone Acetonide Oil recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |