Ranolazine recalls

Ranolazine products have been recalled 2 times, most recently on 16 Apr 2025. The recalling company is usually Glenmark Pharmaceuticals Inc., USA. The most common reason is potency & assay.

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

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 2 100%Class III 0 0%

Why ranolazine is recalled

Potency & Assay150%
Manufacturing (CGMP) Deviations150%

Companies

Glenmark Pharmaceuticals Inc., USA2100%

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., USA	Manufacturing (CGMP) Deviations	Nationwide
15 Nov 2023Drug	CLASS II	Ranolazine Extended-Release Tablets 500mg recalledRanolazine	Glenmark Pharmaceuticals Inc., USA	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., USA	Manufacturing (CGMP) Deviations	Nationwide
15 Nov 2023Drug	CLASS II	Ranolazine Extended-Release Tablets 500mg recalledRanolazine	Glenmark Pharmaceuticals Inc., USA	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.