Class IIReported 2026-03-11
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.
Recalled by Rising Pharma Holding, Inc.
Reason for Recall
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
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Recall NumberD-0384-2026ClassificationClass IIStatusOngoingCategorydrugInitiated2026-03-03Reported2026-03-11DistributionNationwide within the U.SCode InfoLot #: 1TM0524003A, Exp. Date 09/2026.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.