FDA Drug Recalls

Recalls / Active ingredient / Diclofenac Sodium

Diclofenac Sodium

11 FDA drug recalls involving the active ingredient “Diclofenac Sodium.

DateClassProductFirm
2026-01-27Class IIDiclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, OntarioSUN PHARMACEUTICAL INDUSTRIES INC
2025-12-22Class IIIDiclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E JoseCipla USA, Inc.
2023-06-22Class IIDiclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: AleALEMBIC PHARMACEUTICALS, INC.
2019-07-02Class IIAltaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 5Altaire Pharmaceuticals, Inc.
2019-07-02Class IIAltaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDCAltaire Pharmaceuticals, Inc.
2014-09-26Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. ManufactureActavis Laboratories, FL, Inc.
2014-04-24Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, ManufactureActavis Laboratories, FL, Inc.
2014-04-24Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, ManufactureActavis Laboratories, FL, Inc.
2013-12-20Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, ManufactureWatson Laboratories, Inc.-(Actavis) - Florida
2013-03-22Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured Watson Laboratories, Inc.-(Actavis) - Florida
2013-03-22Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson LaboratActavis Inc