Diclofenac recalls
The FDA has published 20 recalls involving Diclofenac since 2012. The latest was reported on 11 Feb 2026. Teligent Pharma has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 20 since 2012
Last 12 months 2 reported
Class I 0 0% of total
Ongoing 4 latest 11 Feb 2026
Recalls per month, last 24 months click a bar for that month Severity split
0 0%18 90%2 10%
Why diclofenac is recalled
Ongoing diclofenac recalls 4 active
All diclofenac recalls, newest first 20 total Reported Class Recall Company Reason Where 11 Feb 2026 Drug CLASS II Diclofenac Sodium, Topical Gel, 3% tube recalled Diclofenac Sodium SUN Pharmaceutical Industries Potency & Assay Nationwide 28 Jan 2026 Drug CLASS III Diclofenac Sodium Topical Gel recalled by Cipla USA Diclofenac Sodium Cipla USA Other Nationwide 2 Aug 2023 Drug CLASS II Diclofenac Sodium Topical Solution USP, 2% w/w recalled Diclofenac Sodium Alembic Pharmaceuticals Other Nationwide 30 Mar 2022 Drug CLASS II Diclofenac Sodium Topical Solution USP, 1.5% w/w recalled Teligent Pharma Potency & Assay Nationwide 30 Mar 2022 Drug CLASS II Diclofenac Sodium Topical Solution USP, 1.5% w/w recalled Teligent Pharma Potency & Assay Nationwide 30 Mar 2022 Drug CLASS II Diclofenac Sodium Topical Solution recalled by Direct Rx Direct Rx Packaging Defects Nationwide 22 Dec 2021 Drug CLASS II Diclofenac Sodium Topical Solution, 1.5% w/w recalled Preferred Pharmaceuticals Potency & Assay CT, FL, KS 1 Dec 2021 Drug CLASS II Diclofenac Sodium Topical Solution USP, 1.5 w/w recalled Teligent Pharma Foreign Material Nationwide 1 Dec 2021 Drug CLASS II Diclofenac Sodium Topical Solution USP, 1.5 w/w recalled Teligent Pharma Foreign Material Nationwide 27 Nov 2019 Drug CLASS II Altaire Diclofenac Sodium Opthalmic Solution recalled Diclofenac Altaire Pharmaceuticals Sterility Nationwide 27 Nov 2019 Drug CLASS II Altaire Diclofenac Sodium Opthalmic Solution recalled Diclofenac Altaire Pharmaceuticals Sterility Nationwide 3 Apr 2019 Drug CLASS III Diclofenac Sodium Topical Solution, 1.5% w/w recalled Ingenus Pharmaceuticals Packaging Defects Nationwide 30 May 2018 Drug CLASS II Diclofenac Sodium and Misoprostol Delayed Release Tablets recalled Exela Pharma Sciences Packaging Defects Nationwide 3 Dec 2014 Drug CLASS II Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled Diclofenac Sodium And Misoprostol Actavis Laboratories FL Other Nationwide 8 Oct 2014 Drug CLASS II Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled Diclofenac Sodium And Misoprostol Actavis Laboratories FL Other Nationwide 8 Oct 2014 Drug CLASS II Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled Diclofenac Sodium And Misoprostol Actavis Laboratories FL Other Nationwide 19 Feb 2014 Drug CLASS II Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled Diclofenac Sodium And Misoprostol Watson Laboratories Inc.-(Actavis) - Florida Potency & Assay Nationwide 12 Feb 2014 Drug CLASS II Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled Diclofenac Sodium And Misoprostol Actavis Other Nationwide 31 Jul 2013 Drug CLASS II Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled Diclofenac Sodium And Misoprostol Watson Laboratories Inc.-(Actavis) - Florida Other Nationwide 22 Aug 2012 Drug CLASS II Diclofenac Sodium, Sdpf - Syringe, 1/2") 500mcg/ Injectable recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide
Should you stop taking Diclofenac?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.