Rising Pharma Recalls Lot of Temozolomide Capsules Following Impurities Concern

Rising Pharma Holding, Inc has initiated a nationwide voluntary recall of temozolomide capsules, 5 mg, packaged in 5-capsule bottles (NDC 64980-333-05). The product, manufactured for Rising Pharmaceuticals, Inc, Allendale, New Jersey, is labeled Rx only and was produced in Taiwan. The recall affects lot number 1TM0524003A with an expiration date of September 2026. A total of 1200 bottles were distributed nationwide within the US. The recall is identified under recall number D-0384-2026 and event ID 98523.

The recall has been classified by the US Food and Drug Administration (FDA) as a Class II recall, indicating that use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, with the probability of serious adverse health consequences considered remote. The action was voluntarily initiated by the firm on March 3, 2026, with the FDA classification occurring on March 4, 2026. The recall remains ongoing. Consignees were notified by letter. No press release has been issued for this recall.

The reason for the recall is failure to meet impurities/degradation specifications, following an out-of-specification result observed during 9-month long-term stability testing. Pharmacists should examine inventory for the affected lot and follow recall instructions provided by the manufacturer. Temozolomide is an alkylating agent indicated primarily for the treatment of certain brain tumors, including newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and as maintenance therapy, as well as for refractory anaplastic astrocytoma.

Reference

FDA. Enforcement Report. March 3, 2026. Accessed March 5, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218982