D-0291-2026 Class III Ongoing

Recalled by Cipla USA, Inc. — Warren, NJ

FDA drug recall D-0291-2026 was initiated by Cipla USA, Inc. on Dec 22, 2025 and is designated Class III. Reason for recall: Failed PH Specifications The recall status is ongoing. Affected quantity: 92,376 tubes.

Recall Details

Product Type
Drugs
Report Date
Jan 28, 2026
Initiation Date
Dec 22, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
92,376 tubes

Product Description

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 for Recall

Failed PH Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Batch XHBG; Exp. 08/31/2027

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0291-2026
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0291-2026. Report a data issue: hello@regdatalab.com.