Fluocinonide recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIOngoing
Summary: SUN PHARMACEUTICAL INDUSTRIES INC is recalling Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.. Reason: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
What is being recalled
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
Why
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot# AD76250, Exp Date: 6/30/2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0477-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 25, 2026 |
| Reported | April 22, 2026 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2,640 60g tubes |
More recalls from SUN PHARMACEUTICAL INDUSTRIES INC · all drug recalls · recalls from March 2026