Official recall notice
FDA DrugClass IINotable
FDA Recall: Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for:
- Recall date
- 2026-03-11
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Recommended action
What to do
1200 bottles
Product description
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing