FDA recall, , Moderate risk
Rising Pharmaceuticals Temozolomide Capsules, 5mg
Temozolomide Capsules failed impurities and degradation specifications during stability testing.
Summary by Recall Canary from the FDA notice
What happened
Rising Pharma Holding, Inc., of East Brunswick, New Jersey, recalled Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, after an out-of-specification result was observed during 9th-month long term stability testing for impurities and degradation specifications. The recall began on March 3, 2026, and was added to the FDA's Enforcement Report on March 4, 2026.
The product was distributed nationwide within the U.S. The recalled capsules are manufactured for Rising Pharmaceuticals, Inc., Allendale, NJ 07401, with a country of origin of Taiwan. The recall involves 1200 bottles.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Temozolomide Capsules, 5mg
- NDC
- 16571-816-51
- Lot code
- 1TM0524003A
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- Rising Pharma Holding, Inc.East Brunswick, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98523
- Recall number
- D-0384-2026
- Quantity recalled
- 1200 bottles
All recalls from Rising Pharma Holding, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
