FDA Recalls Phenytoin Oral Suspension Due to Content Uniformity Failure
The FDA recalled Phenytoin Oral Suspension from Major Pharmaceuticals due to failed content uniformity specifications affecting 3,718 units distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Although no illnesses or injuries have been reported, the failure of content uniformity specifications in a medication presents a significant risk of harm, as inconsistent dosing could compromise patient safety.
Plain-English summary
The FDA has recalled Phenytoin Oral Suspension, USP, 100 mg/4 mL, manufactured by The Harvard Drug Group LLC (doing business as Major Pharmaceuticals and Rugby Laboratories) due to failed content uniformity specifications.
The recall was issued because the medication failed content uniformity specifications, meaning that individual doses may contain inconsistent amounts of the active ingredient. Consistent dosing is critical for medication safety.
The affected product was distributed nationwide. The recall includes Lot Numbers C00099, C00115 (expiration 07/31/2024) and C00079 (expiration 12/31/2023), totaling 3,718 saleable units of the 4 mL unit dose cups.
The recalled product
- Product
- 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
- Category
- Drug — Oral Suspension
- Hazard
- Affected units
- 3,718
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# C00099
- C00115 Exp. date: 07/31/2024
- C00079 Exp. date: 12/31/2023
Distribution
Distributed nationwide across the United States.
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