FDA DrugsClass II
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals ...
Published: April 22, 2026Recall ID: D-0477-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Openfda › Nui › 1 | N0000175576 |
| Openfda › Nui › 2 | N0000175450 |
| Openfda › Unii | 2W4A77YPAN |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 103456 |
| Openfda › Spl id | 3972605f-b081-0289-e063-6294a90ab0e3 |
| Openfda › Brand name | FLUOCINONIDE |
| Openfda › Spl set id | 5782d791-48fd-4cee-853d-235eb4d04a40 |
| Openfda › Package ndc › 1 | 51672-1386-1 |
| Openfda › Package ndc › 2 | 51672-1386-2 |
| Openfda › Package ndc › 3 | 51672-1386-3 |
| Openfda › Package ndc › 4 | 51672-1386-4 |
| Openfda › Product ndc | 51672-1386 |
| Openfda › Generic name | FLUOCINONIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | FLUOCINONIDE |
| Openfda › Pharm class epc | Corticosteroid [EPC] |
| Openfda › Pharm class moa | Corticosteroid Hormone Receptor Agonists [MoA] |
| Openfda › Manufacturer name | Sun Pharmaceutical Industries, Inc. |
| Openfda › Application number | ANDA071500 |
| Openfda › Is original packager | true |
| Event id | 98677 |
| Address 1 | 2 Independence Way |
| Address 2 | N/A |
| Code info | Lot# AD76250, Exp Date: 6/30/2026. |
| Postal code | 08540-6620 |
| Report date | 20260422 |
| Product type | Drugs |
| Product quantity | 2,640 60g tubes |
| Reason for recall | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Initial firm notification | Letter |
| Center classification date | 20260413 |
Overview
- Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA.