Product label: Temozolomide Capsules recall
FDA recall D-0384-2026 · initiated Mar 3, 2026
Rising Pharma Holding, Inc. recalled Product label: Temozolomide Capsules in Mar 2026 — an FDA Class II recall (D-0384-2026) because Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1200 bottles
Details
- Product
- 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.
- Recalling company
- Rising Pharma Holding, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- Mar 3, 2026
- FDA report date
- Mar 11, 2026
Frequently asked
- Was Product label: Temozolomide Capsules recalled?
- Rising Pharma Holding, Inc. recalled Product label: Temozolomide Capsules in Mar 2026 — an FDA Class II recall (D-0384-2026) because Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Product label: Temozolomide Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0384-2026 was: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- Is a recalled Product label: Temozolomide Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Product label: Temozolomide Capsules are affected?
- Distributed: Nationwide within the U.S. The recall covers these lots — Lot #: 1TM0524003A, Exp. Date 09/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0384-2026.