Reported Jan 31, 2024 · Completed

Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries,…

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?

    • Lurasidone Hydrochloride Tablets 120mg
    • Rx Only
    • 30 Tablets per bottle
  • Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
  • Manufactured by
    • Sun Pharmaceutical Industries Ltd
    • Survey No. 259/15
    • Dadra-396 191(U.T. of D & NH)
    • INDIA
    • NDC 47335-579-83
Lot codes and dates
    • Lot #s: DNE0621A Exp. 11/30/2024
    • DNE0815A Exp. 12/31/2024
Amount recalled
9,408 bottles

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

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

Data as of Sep 19, 5:06 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.