Drug & medication recalls Moderate risk

Rising Pharma Holding, Inc. recalls Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuti…

Recall date
March 3, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0384-2026
FDA classification
Class II
Brand / firm
Rising Pharma Holding, Inc.
Sold / distributed
Nationwide within the U.S

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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