Diclofenac Sodium Topical Gel recall (Cipla USA, Inc.)
DrugClass IIIOngoing
Summary: Cipla USA, Inc. is recalling 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. Reason: Failed PH Specifications.
What is being recalled
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
Why
Failed PH Specifications
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Batch XHBG; Exp. 08/31/2027
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-0291-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | December 22, 2025 |
| Reported | January 28, 2026 |
| Company | Cipla USA, Inc. |
| Company location | Warren, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 92,376 tubes |
More recalls from Cipla USA, Inc. · all drug recalls · recalls from December 2025