Reported Dec 1, 2021 · Terminated

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut…

Unichem Pharmaceuticals USA Inc.

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: UNICHEM PHARMACEUTICALS USA INC · 1 Tower Center Blvd Ste 2200 · East Brunswick, NJ · 08816-1145

Is this the product you have?

  • Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only
  • Manufactured byUnichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India
  • Manufactured forUnichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05
Lot codes and dates
    • Lot #: ZTPM20044
    • Exp. Date 09/30/2022
Amount recalled
1284 bottles

Where it was sold

  • Nationwide

Why it was recalled

Discoloration

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 12, 2022 · Data as of Sep 19, 8:01 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.