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Drug FDA Class II Ongoing Failed specifications

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.

Rising Pharma Holding, Inc. Published Mar 11, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Rising Pharma Holding, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

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.

TEMOZOLOMIDE · 1200 bottles

NDC: 16571-816, 16571-817, 16571-818, 16571-819, 16571-820, 16571-821, 16571-816-51, 16571-816-02, 16571-816-41, 16571-817-51, 16571-817-02, 16571-817-41, 16571-818-51, 16571-818-02, 16571-818-41, 16571-819-51, 16571-819-02, 16571-819-41, 16571-820-51, 16571-820-02, 16571-820-41, 16571-821-51, 16571-821-02
Code info: Lot #: 1TM0524003A, Exp. Date 09/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 3, 2026
  2. Published
    Mar 11, 2026
Recall number
D-0384-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.