FDA DrugsClass II
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceu...
Published: February 11, 2026Recall ID: D-0342-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Product Description & Identification
Diclofenac Sodium, Topical Gel, 3%, 100 g 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 51672-1363-7
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Openfda › Unii | QTG126297Q |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 855642 |
| Openfda › Spl id | 38ef9dc7-662f-056c-e063-6394a90a47e2 |
| Openfda › Brand name | DICLOFENAC SODIUM |
| Openfda › Spl set id | aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391 |
| Openfda › Package ndc › 1 | 51672-1363-3 |
| Openfda › Package ndc › 2 | 51672-1363-7 |
| Openfda › Product ndc | 51672-1363 |
| Openfda › Generic name | DICLOFENAC SODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DICLOFENAC SODIUM |
| Openfda › Manufacturer name | Sun Pharmaceutical Industries, Inc. |
| Openfda › Application number | ANDA206298 |
| Openfda › Is original packager | true |
| Event id | 98351 |
| Address 1 | 2 Independence Way |
| Address 2 | N/A |
| Code info | Lot # AD92721, Exp Date: 3/31/2027. |
| Postal code | 08540-6620 |
| Report date | 20260211 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260127 |
| Initial firm notification | Letter |
| Center classification date | 20260223 |
Overview
- Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.