Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 16571-0816-51 recalled?

Temozolomide · 5 CAPSULE in 1 BOTTLE (16571-816-51)

Yes — this exact package was recalled

1 FDA recall names the code 16571-0816-51 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

1 of these recalls is still ongoing.

Active ingredient
temozolomide
Strength
TEMOZOLOMIDE 5 mg/1
Form
Capsule · Oral
Labeler
Rising Pharma Holdings, Inc.
Type
Human Prescription Drug
Product code
16571-0816

Recalls naming this package

Class II ยท Moderate risk

Product label: Temozolomide Capsules

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

Ongoing Impurity / degradation Rising Pharma Holding, Inc. NDC 16571-816-51 D-0384-2026

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler