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Temozolomide Capsules 5mg
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DRUG RECALLMODERATE

Temozolomide Capsules 5mg

Rising Pharmaceuticals is recalling Temozolomide Capsules 5mg (NDC 16571-816-51) due to failed impurities and degradation specifications.

What to do

Do not use this medication. Contact your pharmacy or healthcare provider immediately to obtain a replacement or alternative treatment. Return the recalled product to your pharmacy.

Recalled
Listed
Updated
Recall No.
D-0384-2026
Agency
FDA
Firm
Rising Pharma Holding, Inc.
Recall ID
98523
Status
ONGOING

Recall at a glance

Quantity recalled
1200 bottles

Why it was recalled

Rising Pharmaceuticals is recalling Temozolomide Capsules, 5mg, packaged in 5-capsule bottles (NDC 16571-816-51) due to failed impurities and degradation specifications observed during stability testing. The affected product was manufactured in Taiwan and distributed nationwide.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Product label: Temozolomide Capsules

Strength
5 mg
NDC / UPC
NDC 16571-816-51

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification