Temozolomide Capsule
FDA Recall NDC 16571-821
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Temozolomide (NDC 16571-821). A significant event, classified as Class II, was initiated on Mar 03, 2026 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Mar 03, 2026
Mar 11, 2026
1200 bottles
Recall Profile & Regulatory Data
Event ID
98523
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Rising Pharma Holding, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
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.
Batch or Lot Expiration Information
Lot# : 1TM0524003A, Exp. Date 09/2026.
Affected Packages Involved in this Recall
16571-816-51Product
16571-816-02Product
16571-816-41Product
16571-817-51Product
16571-817-02Product
16571-817-41Product
16571-818-51Product
16571-818-02Product
16571-818-41Product
16571-819-51Product
16571-819-02Product
16571-819-41Product
16571-820-51Product
16571-820-02Product
16571-820-41Product
16571-821-51Product
16571-821-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
