CLASS II ONGOING Drug recall · Reported 11 Mar 2026 · FDA Enforcement Report
Product label: Temozolomide Capsules, 5mg recalled
Rising Pharma Holding is recalling Product label: Temozolomide Capsules, 5mg, distributed nationwide in the US. The recall was initiated on 3 Mar 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0384-2026
- FDA event ID
- 98523
- Recalling firm
- Rising Pharma Holding, East Brunswick, NJ
- Brand
- Temozolomide
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Mar 2026
- FDA classified
- 4 Mar 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 3 Mar 2026 | Recall initiated by company | |
| 4 Mar 2026 | Classified by FDA | +1 day |
| 11 Mar 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Which lots are affected?
Lot #: 1TM0524003A, Exp. Date 09/2026.
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Rising Pharma Holding
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rising, Cyproheptadine Hydrochloride Syrup, 2mg recalledCyproheptadine Hydrochloride | Rising Pharma Holding | Particulate Matter | Nationwide |
| Drug | CLASS II | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg recalledCarbidopa, Levodopa And Entacapone | Rising Pharma Holding | Packaging Defects | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30 mg recalled | Rising Pharma Holding | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP 20 mg recalled | Rising Pharma Holding | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine DR Capsules USP 60 mg, a) recalled by Rising Pharma Holding | Rising Pharma Holding | Nitrosamine Impurity | Nationwide |
Other Temozolomide recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Temozolomide Capsules, 5 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 140 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 250 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 20 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 100 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |