# FDA recall D-0384-2026

> **Rising Pharma Holding, Inc.** · Class II · drug recall initiated 2026-03-03.

## 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.

## Reason for recall

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

## Distribution

Nationwide within the U.S

## Key facts

- **Recall number:** D-0384-2026
- **Recalling firm:** Rising Pharma Holding, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-03
- **Report date:** 2026-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0384-2026

## Citation

> AI Analytics. FDA recall D-0384-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0384-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*