FDA-Drug2026-03-11Class IICHEMICAL
Rising Pharma Temozolomide 5mg capsules recalled for failed stability testing
What this means
Rising Pharmaceuticals is recalling specific bottles of Temozolomide 5mg capsules because testing found the medication didn't meet quality standards for purity and stability. The issue was discovered during routine 9-month stability testing. This affects 1,200 bottles distributed nationwide with expiration date 09/2026.
- Check if you have Temozolomide 5mg capsules from Rising Pharmaceuticals with lot #1TM0524003A and expiration date 09/2026.
- Do not use the medication if you have this lot number.
- Contact your pharmacy or doctor for a replacement or alternative medication.
- Return the recalled medication to your pharmacy.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
1200 bottles
Manufactured in
2 Tower Center Blvd Ste 1401, N/A, East Brunswick, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0384-2026More Rising Pharma recalls
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