Ranolazine recalls
The FDA has published 4 recalls involving Ranolazine since 2014. The latest was reported on 7 Oct 2026. Most were for potency & assay. Glenmark Pharmaceuticals Inc., USA 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 recalls4since 2014
Last 12 months1reported
Class I00% of total
Ongoing3latest 7 Oct 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 4 100%Class III 0 0%
Why ranolazine is recalled
Companies
By year
Ongoing ranolazine recalls
3 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranolazine Extended-Release Tablets, 1000 mg recalledRanolazine | Ajanta Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranolazine Extended-Release Tablets 1000mg recalledRanolazine | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ranolazine Extended-Release Tablets 500mg recalledRanolazine | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
All ranolazine recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranolazine Extended-Release Tablets, 1000 mg recalledRanolazine | Ajanta Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranolazine Extended-Release Tablets 1000mg recalledRanolazine | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ranolazine Extended-Release Tablets 500mg recalledRanolazine | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranolazine ER Tablet, 500 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
Should you stop taking Ranolazine?
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.