Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Consumers and healthcare providers should stop using this product immediately. Contact Rising Pharma Holding, Inc. or your healthcare provider for guidance. Notification method: Letter
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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, NDC 16571-816-51.. Generic: TEMOZOLOMIDE; Brand: TEMOZOLOMIDE. Reason: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing. Classification: Class II. Quantity: 1200 bottles. Distribution: Nationwide within the U.S
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Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Defective container; inadequately sealed blister packaging.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution