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Class II · ModerateActive recall

Temozolomide

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 1TM0524003A, Exp. Date 09/2026.
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byRising Pharma Holdings, Inc.
Brand nameTEMOZOLOMIDE
Generic nameTEMOZOLOMIDE
Active ingredient(s)TEMOZOLOMIDE
Distributed by / forRising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan
NDC16571-816-51
Show the full FDA record
Full product labelProduct 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.
Recalling firmRising Pharma Holding, Inc.
DistributionNationwide within the U.S
Quantity1200 bottles
Recall initiated2026-03-03
Report date2026-03-11
Recall completed—
Recall numberD-0384-2026
ClassificationClass II
FDA statusOngoing
Origin on fileEast Brunswick NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.