Temozolomide recalls
The FDA has published 17 recalls involving Temozolomide since 2017. The latest was reported on 11 Mar 2026. Most were for manufacturing (cgmp) deviations. Deva Holding AS - Cerkezkoy Subesi 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 recalls 17 since 2017
Last 12 months 1 reported
Class I 0 0% of total
Ongoing 1 latest 11 Mar 2026
Recalls per month, last 24 months click a bar for that month Severity split
0 0%13 76%4 24%
Why temozolomide is recalled
Ongoing temozolomide recalls 1 active
All temozolomide recalls, newest first 17 total Reported Class Recall Company Reason Where 11 Mar 2026 Drug CLASS II Product label: Temozolomide Capsules, 5mg recalled Temozolomide Rising Pharma Holding Potency & Assay Nationwide 31 Jul 2019 Drug CLASS II Temozolomide Capsules, 5 mg recalled by Deva Holding AS - Cerkezkoy Temozolomide Deva Holding AS - Cerkezkoy Subesi Manufacturing (CGMP) Deviations Nationwide 31 Jul 2019 Drug CLASS II Temozolomide Capsules, 140 mg recalled by Deva Holding AS - Cerkezkoy Temozolomide Deva Holding AS - Cerkezkoy Subesi Manufacturing (CGMP) Deviations Nationwide 31 Jul 2019 Drug CLASS II Temozolomide Capsules, 250 mg recalled by Deva Holding AS - Cerkezkoy Temozolomide Deva Holding AS - Cerkezkoy Subesi Manufacturing (CGMP) Deviations Nationwide 31 Jul 2019 Drug CLASS II Temozolomide Capsules, 20 mg recalled by Deva Holding AS - Cerkezkoy Temozolomide Deva Holding AS - Cerkezkoy Subesi Manufacturing (CGMP) Deviations Nationwide 31 Jul 2019 Drug CLASS II Temozolomide Capsules, 100 mg recalled by Deva Holding AS - Cerkezkoy Temozolomide Deva Holding AS - Cerkezkoy Subesi Manufacturing (CGMP) Deviations Nationwide 31 Jul 2019 Drug CLASS II Temozolomide Capsules, 180 mg recalled by Deva Holding AS - Cerkezkoy Temozolomide Deva Holding AS - Cerkezkoy Subesi Manufacturing (CGMP) Deviations Nationwide 27 Feb 2019 Drug CLASS III Temozolomide Capsules, 5 mg recalled by Amerigen Pharmaceuticals Amerigen Pharmaceuticals Potency & Assay Nationwide 2 Jan 2019 Drug CLASS III Temozolomide Capsules, 20 mg recalled by Amerigen Pharmaceuticals Amerigen Pharmaceuticals Potency & Assay NJ 2 Jan 2019 Drug CLASS III Temozolomide Capsules, 180 mg recalled by Amerigen Pharmaceuticals Amerigen Pharmaceuticals Potency & Assay NJ 24 Oct 2018 Drug CLASS III Temozolomide capsules, 20 mg recalled by Amerigen Pharmaceuticals Amerigen Pharmaceuticals Potency & Assay Nationwide 16 May 2018 Drug CLASS II Temozolomide 20 mg recalled by Kroger Specialty Pharmacy Kroger Specialty Pharmacy Other 5 states 16 May 2018 Drug CLASS II Temozolomide 250 mg recalled by Kroger Specialty Pharmacy Kroger Specialty Pharmacy Other 5 states 1 Feb 2017 Drug CLASS II Temozolomide Capsules, 140 mg recalled by Mylan Mylan Packaging Defects Nationwide 1 Feb 2017 Drug CLASS II Temozolomide Capsules, 180 mg recalled by Mylan Mylan Packaging Defects Nationwide 1 Feb 2017 Drug CLASS II Temozolomide Capsules, 250 mg recalled by Mylan Mylan Other Nationwide 1 Feb 2017 Drug CLASS II Temozolomide Capsules, 100 mg recalled by Mylan Mylan Packaging Defects Nationwide
Should you stop taking Temozolomide?
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.