Reported Mar 4, 2020 · Terminated

Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries…

Taro Pharmaceuticals U.S.A., Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174

Is this the product you have?

    • Phenytoin Oral Suspension USP
    • 125 mg/5 mL potency
    • 8 fl oz (237 mL) Rx Only Mfd
  • byTaro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist
  • by
    • Taro Pharmaceuticals U.S.A. Inc. Hawthorne
    • NY 10532
    • NDC 51672-4069-1
Lot codes and dates
    • Lot# 327874
    • 327876
    • Exp Dec/2020
Amount recalled
29,172 8 Fl Oz bottles

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

Using this product could cause serious injury, illness or death — stop using it now.

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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 11, 2023 · Data as of Sep 19, 7:18 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.