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Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan,…

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

Class II Medicine & devices FDA March 11, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Rising Pharma Holding, Inc. — East Brunswick, NJ
Severity
Class II — moderate
Reported
March 11, 2026
Quantity
1200 bottles
Recall number
D-0384-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide within the U.S

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