Reported Mar 8, 2017 · Terminated

Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical…

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. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605

Is this the product you have?

  • Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only
  • Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
  • Manufactured bySun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88
Lot codes and dates
    • Lot #: JKR5219A
    • JKR5200A
    • JKR5220A
    • JKR5221A
    • JKR5222A
    • Exp 03/18
Amount recalled
22,915 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.

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 foreign material 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 Jun 29, 2018 · Data as of Sep 19, 7:47 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.