Reported Mar 11, 2026 · Ongoing

Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising…

Rising Pharma Holding, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Rising Pharma Holding, Inc. · 2 Tower Center Blvd Ste 1401 · East Brunswick, NJ · 08816-1149

Is this the product you have?

  • Product labelTemozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only
  • Manufactured forRising Pharmaceuticals, Inc., Allendale, NJ 07401
  • Country of originTaiwan, NDC 16571-816-51
Lot codes and dates
    • Lot #: 1TM0524003A
    • Exp. Date 09/2026
Amount recalled
1200 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.