Reported Apr 4, 2018 · Terminated

Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd.,…

Glenmark Pharmaceuticals Inc., USA

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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

  • Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only
  • Manufactured byGlenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India
  • Manufactured forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01
Lot codes and dates
    • Lot #: 19172776
    • 19172794
    • Exp 07/19
    • 19173111
    • 19173186
    • 19173188
    • 19173189
    • Exp 08/19
    • 19173852
    • 19173878
    • 19173893
    • Exp 10/19
    • 19174318
    • 19174341
    • Exp 11/19
Amount recalled
109,080 Bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.

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 Dec 16, 2019 · Data as of Sep 19, 5:02 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.