Temozolomide capsules recalled after failing impurities and degradation specifications
Rising Pharma Holding is recalling one lot of Temozolomide Capsules 5 mg after an out-of-specification result was observed during nine-month long-term stability testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the medicine failed an impurities and degradation specification rather than an appearance test, and no injuries are stated in the source.
Plain-English summary
Rising Pharma Holding, Inc. is recalling Temozolomide Capsules, 5 mg, in 5-capsule bottles, prescription only, made for Rising Pharmaceuticals, Inc. of Allendale, New Jersey, country of origin Taiwan, NDC 16571-816-51. About 1,200 bottles were distributed nationwide within the United States. The FDA has classified this recall as Class II.
The recall was initiated for failed impurities and degradation specifications: an out-of-specification result was observed during ninth-month long term stability testing.
Affected product is lot 1TM0524003A with an expiry date of 09/2026.
Patients and pharmacies can identify affected product by the NDC, lot number and expiry date above, and may contact Rising Pharma Holding, Inc. for further information.
The recalled product
- Product
- TEMOZOLOMIDE (TEMOZOLOMIDE)
- Brand
- TEMOZOLOMIDE
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug — Prescription capsule
- Affected units
- 1,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1TM0524003A
- Exp. Date 09/2026.
Distribution
Distributed nationwide across the United States.
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