Diclofenac recalls

The FDA has published 6 recalls involving Diclofenac since 2018. The latest was reported on 11 Feb 2026. Most were for potency & assay. Altaire Pharmaceuticals 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 recalls6since 2018

Last 12 months2reported

Class I00% of total

Ongoing3latest 11 Feb 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 1Jan '26 1 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 83%Class III 1 17%

Why diclofenac is recalled

Companies

Brands

Diclofenac Sodium350%
Diclofenac233%

By year

2026233%
2023117%
2019233%
2018117%

Ongoing diclofenac recalls

3 active

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Drug	CLASS II	Diclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac Sodium	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
28 Jan 2026Drug	CLASS III	Diclofenac Sodium Topical Gel recalled by Cipla USADiclofenac Sodium	Cipla USA	Other	Nationwide
2 Aug 2023Drug	CLASS II	Diclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac Sodium	Alembic Pharmaceuticals	Other	Nationwide

All diclofenac recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Drug	CLASS II	Diclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac Sodium	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
28 Jan 2026Drug	CLASS III	Diclofenac Sodium Topical Gel recalled by Cipla USADiclofenac Sodium	Cipla USA	Other	Nationwide
2 Aug 2023Drug	CLASS II	Diclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac Sodium	Alembic Pharmaceuticals	Other	Nationwide
27 Nov 2019Drug	CLASS II	Altaire Diclofenac Sodium Opthalmic Solution recalledDiclofenac	Altaire Pharmaceuticals	Sterility	Nationwide
27 Nov 2019Drug	CLASS II	Altaire Diclofenac Sodium Opthalmic Solution recalledDiclofenac	Altaire Pharmaceuticals	Sterility	Nationwide
28 Feb 2018Drug	CLASS II	Diclofenac Sodium USP for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	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.