Reported May 1, 2019 · Terminated

Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.…

Lupin Somerset

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: LUPIN SOMERSET · 400 Campus Dr · Somerset, NJ · 08873-1145

Is this the product you have?

  • Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only
  • Manufactured byNovel Laboratories, Inc. Somerset
  • NJ 08873 Manufactured forLupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
Lot codes and dates
    • Lot#: S700220
    • Exp. Apr 30 2019
    • S700604
    • Exp. July 31 2019
    • S800326
    • Exp. Mar 31 2020
Amount recalled
17,328 bottles

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Why it was recalled

Failed Impurities/Degradation Specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 14, 2022 · Data as of Sep 19, 8:06 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.