Reported Feb 7, 2024 · Ongoing

Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort…

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?

    • Budesonide Extended-Release Tablets 9mg
    • 30-count bottle
    • Rx Only
  • Manufactured byActavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA
  • Distributed byActavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
Lot codes and dates
    • Lot # 100047273
    • Exp. 07/2025
Amount recalled
10,672 30-count bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

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

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:24 PM UTC

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