FDA DrugsClass III
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT ...
Published: January 28, 2026Recall ID: D-0291-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed PH Specifications
Product Description & Identification
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Affected Products
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Openfda › Unii | QTG126297Q |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 855633 |
| Openfda › Spl id | 6fc74e92-7f37-41e7-aa8b-8fd0275a57c9 |
| Openfda › Brand name | DICLOFENAC SODIUM |
| Openfda › Spl set id | be25c19e-cbea-4f87-a581-9f0d350e5adf |
| Openfda › Package ndc | 76282-103-39 |
| Openfda › Product ndc | 76282-103 |
| Openfda › Generic name | DICLOFENAC SODIUM |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | DICLOFENAC SODIUM |
| Openfda › Manufacturer name | EXELAN PHARMACEUTICALS INC. |
| Openfda › Application number | ANDA209903 |
| Openfda › Is original packager | true |
| Event id | 98193 |
| Address 1 | 10 Independence Blvd |
| Code info | Batch XHBG; Exp. 08/31/2027 |
| Postal code | 07059-2730 |
| Report date | 20260128 |
| Product type | Drugs |
| Product quantity | 92,376 tubes |
| Reason for recall | Failed PH Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251222 |
| Initial firm notification | Letter |
| Center classification date | 20260120 |
Overview
- Recalling FirmCipla USA, Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide in the USA