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CLASS III · LowFDA

Cipla USA, Inc. recalls Diclofenac Sodium Topical Gel

📅 Dec 22, 2025 · 📍 Nationwide
Recalling company
Cipla USA, Inc.
Product
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
Classification
Class III – not likely to cause adverse health consequences
Recall date
Dec 22, 2025
Reported
Jan 28, 2026
Distribution
Nationwide in the USA
Status
Ongoing
Quantity
92,376 tubes
Lot / codes
Batch XHBG; Exp. 08/31/2027
Company location
Warren, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0291-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0291-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.