Ranolazine recalls

Ranolazine products have been recalled 3 times, most recently on 7 Oct 2026. The recalling company is usually Glenmark Pharmaceuticals Inc., USA. The most common reason is potency & assay.

Total recalls3since 2023

Last 12 months1reported

Class I00% of total

Ongoing3latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 1 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 1 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why ranolazine is recalled

Potency & Assay267%
Manufacturing (CGMP) Deviations133%

Companies

Glenmark Pharmaceuticals Inc., USA267%
Ajanta Pharma USA133%

By year

2026133%
2025133%
2023133%

Ongoing ranolazine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Ranolazine Extended-Release Tablets, 1000 mg recalledRanolazine	Ajanta Pharma USA	Potency & Assay	Nationwide
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

3 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Ranolazine Extended-Release Tablets, 1000 mg recalledRanolazine	Ajanta Pharma USA	Potency & Assay	Nationwide
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.