UnratedDrug recall · FDA · Published March 3, 2026
Rising Pharma Recalls Temozolomide 5mg Capsules Due to Impurity Issues
Rising Pharmaceuticals recalls 1200 bottles of Temozolomide 5mg capsules due to failed impurity specifications. Check your lot number and expiration date.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Take action
Contact the company
📍Recalling firmRising Pharma Holding, Inc.2 Tower Center Blvd Ste 1401 · East Brunswick, NJ 08816-1149
✎ GovInfoNow plain-language explainer
Rising Pharma Holding, Inc. is recalling one lot of Temozolomide Capsules, 5mg, because they failed impurity specifications during stability testing. The affected product was manufactured for Rising Pharmaceuticals, Inc., and distributed nationwide in the U.S. No remedy or specific health risks are currently described in the record. Read more at govinfonow.com/recall/31454-rising-pharma-recalls-temozolomide-5mg-capsules-due-to-impurity-issues.
“Rising Pharma Recalls Temozolomide 5mg Capsules Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31454-rising-pharma-recalls-temozolomide-5mg-capsules-due-to-impurity-issues. Based on FDA recall #D-0384-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0384-2026%22&limit=1).
The FDA announced on March 3, 2026, that Rising Pharmaceuticals is recalling Temozolomide Capsules, 5mg, due to failed impurity specifications. The agency issued the recall after out-of-specification results were observed during stability testing.
How to tell if you have it
Brand: Rising Pharmaceuticals
Product: Temozolomide Capsules 5mg
Packaging: 5-capsule bottles, Rx only
NDC: 16571-816-51
Lot #: 1TM0524003A
Exp. Date: 09/2026
Manufacturer location: Allendale, NJ 07401
Country of origin: Taiwan
Units affected: 1200 bottles
Distribution: Nationwide within the U.S.
The hazard
The recall is due to failed impurity or degradation specifications. The FDA stated that an out-of-specification result was observed during ninth-month long-term stability testing of the product.
Context
GovInfoNow's records show Rising Pharma Holding, Inc. has eight other recalls on record since December 29, 2023. Other recent recalls of similar products include Rising Pharma Recalls Cyproheptadine Syrup Due to Crystallization (July 13, 2026), Rising Pharma recalls Carbidopa Levodopa Entacapone tablets due to incorrect strength (Oct. 7, 2025), and Rising Pharma recalls Duloxetine 30mg capsules due to impurity risk (March 5, 2025). Other recent recalls of similar products include Ascend Laboratories recalls Dabigatran Etexilate Capsules due to impurity risks (July 16, 2026), Zydus Recalls Bromocriptine Mesylate Capsules Due to Impurity Issues (Oct. 23, 2025), and Appco Pharma Recalls Prazosin Capsules Due to Nitrosamine Impurity Risk (March 27, 2026).
How to tell if you have this one
Check if you have Temozolomide Capsules, 5mg, packaged in 5-capsule bottles with NDC 16571-816-51. Verify the lot number is 1TM0524003A and the expiration date is 09/2026.
Brand
Rising Pharmaceuticals
Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 8 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0384-2026 (March 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0384-2026 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.