Naproxen Sodium recalls

Naproxen Sodium products have been recalled 5 times, most recently on 16 Apr 2025. The recalling company is usually Glenmark Pharmaceuticals Inc., USA. The most common reason is manufacturing (cgmp) deviations.

Total recalls5since 2012

Last 12 months0reported

Class I00% of total

Ongoing2latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why naproxen sodium is recalled

Manufacturing (CGMP) Deviations360%
Packaging Defects240%

Companies

Product types

Pain Medication5100%

By year

2025120%
2023120%
2021240%
2012120%

Ongoing naproxen sodium recalls

2 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Naproxen Sodium Tablets, USP, 550mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
6 Dec 2023Drug	CLASS II	Naproxen Tablets, USP 250mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide

All naproxen sodium recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Naproxen Sodium Tablets, USP, 550mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
6 Dec 2023Drug	CLASS II	Naproxen Tablets, USP 250mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
29 Sep 2021Drug	CLASS II	Naproxen Sodium Tablets, USP 275 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021Drug	CLASS II	Naproxen Sodium Tablets, USP 550 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
3 Oct 2012Drug	CLASS II	Naproxen Tablets recalled by Glenmark Generics Inc., UNaproxen Sodium	Glenmark Generics Inc. USA	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.