Imatinib recalls
The FDA has published 4 recalls involving Imatinib since 2018. The latest was reported on 3 Mar 2021. Most were for manufacturing (cgmp) deviations. Shilpa Medicare 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 2018
Last 12 months0reported
Class I00% of total
Ongoing0latest 3 Mar 2021
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 imatinib is recalled
Companies
Brands
By year
All imatinib recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Imatinib Mesylate Tablets 100mg, packaged as a) bottles recalledImatinib | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Imatinib Mesylate Tablets 100 mg recalled by Shilpa MedicareImatinib Mesylate | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Imatinib Mesylate Tablets 400 mg recalled by Shilpa MedicareImatinib Mesylate | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Imatinib Mesylate Tablet 400 mg recalled by Kroger Specialty Pharmacy | Kroger Specialty Pharmacy | Other | 5 states |
Should you stop taking Imatinib?
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.