Temozolomide recalls: 7 FDA reports
Recalls involving Temozolomide. What was wrong with each batch, and how the FDA graded the risk.
7Reports
0Class I
1Ongoing
2026-03-11Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Ph
D-0384-2026 · Class II · reported 2026-03-11 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- Product
- Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
- Where it went
- Nationwide within the U.S
- How much
- 1200 bottles
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877
D-1512-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Product
- Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Where it went
- Nationwide in the USA.
- How much
- a) 5052 bottles; b) 3816 bottles
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877
D-1510-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Product
- Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Where it went
- Nationwide in the USA.
- How much
- a) 13752 bottles; b) 15696 bottles
Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-
D-1509-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Product
- Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Where it went
- Nationwide in the USA.
- How much
- a) 11376 bottles; b) 13620 bottles
Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi
D-1513-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Product
- Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.
- Where it went
- Nationwide in the USA.
- How much
- 11472 bottles
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877
D-1511-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Product
- Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Where it went
- Nationwide in the USA.
- How much
- a) 7380 bottles; b) 10332 bottles
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-5
D-1508-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Product
- Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Where it went
- Nationwide in the USA.
- How much
- a) 5736 bottles; b) 8460 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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