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Class II · ModerateRecall completed

Sunitinib Malate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 100037220, Exp 10/2024
Where it was soldProduct was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTeva Pharmaceuticals USA, Inc., Parsippany, NJ 07054
Brand nameSUNITINIB MALATE
Generic nameSUNITINIB MALATE
Active ingredient(s)SUNITINIB MALATE
Distributed by / forTeva Pharmaceuticals USA Inc
NDC0093-8199-28
Show the full FDA record
Full product labelSunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Recalling firmTeva Pharmaceuticals USA Inc
DistributionProduct was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Quantity180 bottles
Recall initiated2023-07-05
Report date2023-07-19
Recall completed2024-01-10
Recall numberD-0913-2023
ClassificationClass II
FDA statusTerminated
Origin on fileParsippany NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.