Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Product label: Temozolomide Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
16571-0816-51
Compare with the code on your package — it is the most precise check available.
Drug: Temozolomide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Temozolomide NDC 16571-0816 |
5 mg/1 | Capsule Oral |
Rising Pharma Holdings, Inc. | Rx |
- Recalling firm
- Rising Pharma Holding, Inc.
- NDC code
- 16571-816-51
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0384-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Temozolomide recalls
See all
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Other recalls by Rising Pharma Holding, Inc.
All 2026 recalls
Class II · Moderate risk
Rising
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Class II · Moderate risk
Carbidopa
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Duloxetine DR Capsules USP 60 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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