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 Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Due to Failed Content Uniformity Specifications
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 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories directly.
Affected Products
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Quantity: 3718 saleable units
Why Was This Recalled?
Failed Content Uniformity Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report