Sulfamethoxazole recalls

The FDA has published 10 recalls involving Sulfamethoxazole since 2014. The latest was reported on 24 Sep 2025. Most were for packaging defects. The Harvard Drug Group 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 recalls10since 2014

Last 12 months1reported

Class I110% of total

Ongoing5latest 24 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 1 0Jul 0 4 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 10%Class II 9 90%Class III 0 0%

Why sulfamethoxazole is recalled

Companies

By year

2025550%
2022110%
2021110%
2020110%
2018110%
2014110%

Ongoing sulfamethoxazole recalls

5 active

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Northwind Pharmaceuticals	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Packaging Defects	Nationwide
18 Jun 2025Drug	CLASS I	Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Sterility	Nationwide

All sulfamethoxazole recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Northwind Pharmaceuticals	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Packaging Defects	Nationwide
18 Jun 2025Drug	CLASS I	Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
18 Aug 2021Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Aurobindo Pharma USA	Foreign Material	Nationwide
2 Sep 2020Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Aurobindo Pharma USA	Foreign Material	Nationwide
23 May 2018Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	Sun Pharmaceutical Industries	Foreign Material	Nationwide
30 Jul 2014Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	Shamrock Medical Solutions Group	Packaging Defects	5 states

Should you stop taking Sulfamethoxazole?

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.