Reported Jul 19, 2023 · Terminated

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc.,…

Teva Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120

Is this the product you have?

  • Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only
  • Manufactured ByTeva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Lot codes and dates
    • Lot # 100037220
    • Exp 10/2024
Amount recalled
180 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Teva Pharmaceuticals USA Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 10, 2024 · Data as of Sep 19, 6:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.