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Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufa… Recalled: Failed Impurities/Degradation Specifications: An out-of-specification result observed dur…

Product label: Temozolomide Capsules, 5mg, packaged in… was recalled on March 3, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing.

Is my unit affected?

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.

Model, lot & date codes to check

Lot #: 1TM0524003A, Exp. Date 09/2026.

Units affected: 1200 bottles

Where it was sold: Nationwide within the U.S

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

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

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: Rising Pharma Holding, Inc.

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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