Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Phenytoin Oral Suspension USP Recalled by Taro Pharmaceuticals U.S.A., Inc. Due to Resuspension Problems: Two lots of Phenytoin Oral Suspension...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Taro Pharmaceuticals U.S.A., Inc. directly.
Affected Products
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
Quantity: 29,172 8 Fl Oz bottles
Why Was This Recalled?
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Taro Pharmaceuticals U.S.A., Inc.
Taro Pharmaceuticals U.S.A., Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report