CLASS III Drug recall · Reported 1 Nov 2017 · FDA Enforcement Report
Fluocinonide Gel USP, 0.05% tube recalled by Taro Pharmaceuticals U.S.A
Taro Pharmaceuticals U is recalling Fluocinonide Gel USP, 0.05% tube, distributed nationwide in the US. The recall was initiated on 20 Sep 2017 and the FDA has classified it as Class III.
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-0146-2018
- FDA event ID
- 78157
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Brand
- Fluocinonide
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Sep 2017
- FDA classified
- 29 Dec 2017
- Reported
- 1 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 20 Sep 2017 | Recall initiated by company | |
| 1 Nov 2017 | Published in enforcement report | +42 days |
| 29 Dec 2017 | Classified by FDA | +58 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross contamination with other products: traces of Dapsone were found in the finished product.
Product as listed by the FDA
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Cross contamination with other products: traces of Dapsone were found in the finished product.
Which lots are affected?
Lot #: A771026850, Exp 6/18
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Taro Pharmaceuticals U
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS III | Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS I | Clobetasol Propionate Ointment USP, 0.05% tubes recalledClobetasol Propionate | Taro Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride | Taro Pharmaceuticals U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB | Taro Pharmaceuticals U | Potency & Assay | Nationwide |
Other Fluocinonide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Topical Solution recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Gel recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |