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FDAMarch 3, 2026drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

rising pharma holdingrisingrising pharma

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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