Reported May 31, 2023 · Terminated

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun…

Sun Pharmaceutical Industries 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: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only
  • Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ
  • Manufactured bySun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Lot codes and dates
  • Lots
    • HAC2240A
    • Exp 05/2023
    • HAC3162A
    • Exp 07/2023
Amount recalled
5,344 Bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications; during stability testing

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

Notice updated Feb 27, 2024 · Data as of Sep 19, 7:55 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.