Ranolazine recalls

Ranolazine products have been recalled 2 times, most recently on 16 Apr 2025. The recalling company is usually Glenmark Pharmaceuticals Inc., U. The most common reason is manufacturing (cgmp) deviations.

Total recalls2since 2023

Last 12 months0reported

Class I00% of total

Ongoing2latest 16 Apr 2025

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 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why ranolazine is recalled

Manufacturing (CGMP) Deviations150%
Potency & Assay150%

Companies

Glenmark Pharmaceuticals Inc., U2100%

By year

2025150%
2023150%

Ongoing ranolazine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Ranolazine Extended-Release Tablets 1000mg recalledRanolazine	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
15 Nov 2023Drug	CLASS II	Ranolazine Extended-Release Tablets 500mg recalledRanolazine	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide

All ranolazine recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Ranolazine Extended-Release Tablets 1000mg recalledRanolazine	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
15 Nov 2023Drug	CLASS II	Ranolazine Extended-Release Tablets 500mg recalledRanolazine	Glenmark Pharmaceuticals Inc., U	Potency & Assay	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.