Naproxen recalls

The FDA has published 6 recalls involving Naproxen since 2012. The latest was reported on 13 May 2026. Most were for manufacturing (cgmp) deviations. Glenmark Pharmaceuticals Inc., U 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 2012

Last 12 months1reported

Class I00% of total

Ongoing3latest 13 May 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why naproxen is recalled

Companies

Brands

Naproxen Sodium583%
Naproxen117%

By year

2026117%
2025117%
2023117%
2021233%
2012117%

Ongoing naproxen recalls

3 active

Reported	Class	Recall	Company	Reason	Where
13 May 2026Drug	CLASS II	Naproxen Oral Suspension, USP, 125 mg recalled by Acella PharmaceuticalsNaproxen	Acella Pharmaceuticals	Lead & Heavy Metals	Nationwide
16 Apr 2025Drug	CLASS II	Naproxen Sodium Tablets, USP, 550mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
6 Dec 2023Drug	CLASS II	Naproxen Tablets, USP 250mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide

All naproxen recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
13 May 2026Drug	CLASS II	Naproxen Oral Suspension, USP, 125 mg recalled by Acella PharmaceuticalsNaproxen	Acella Pharmaceuticals	Lead & Heavy Metals	Nationwide
16 Apr 2025Drug	CLASS II	Naproxen Sodium Tablets, USP, 550mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
6 Dec 2023Drug	CLASS II	Naproxen Tablets, USP 250mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide
29 Sep 2021Drug	CLASS II	Naproxen Sodium Tablets, USP 275 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021Drug	CLASS II	Naproxen Sodium Tablets, USP 550 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
3 Oct 2012Drug	CLASS II	Naproxen Tablets recalled by Glenmark Generics Inc., UNaproxen Sodium	Glenmark Generics Inc., U	Packaging Defects	Nationwide

Should you stop taking Naproxen?

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.