Reported Jul 29, 2015 · Terminated

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by:…

Wockhardt 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: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271

Is this the product you have?

  • Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only
  • Manufactured byWockhardt Limited, Mumbai, India
  • Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
  • NDC64679-0669-01
Lot codes and dates
  • Lot #: LN11008
  • Expiry4/30/2015
Amount recalled
16,276 Bottles

This recall covers 35 products

The agency filed one notice per product. You are reading one of them; the other 34 are below.

22 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

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 May 9, 2018 · Data as of Sep 19, 7:57 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.