Phenytoin Oral Suspension (Major) – content uniformity issue (2023)
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lot Codes / Batch Numbers
Lot# C00099, C00115 Exp. date: 07/31/2024, C00079 Exp. date: 12/31/2023
Products Sold
Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories is recalling Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7 due to Failed Content Uniformity Specifications. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Content Uniformity Specifications
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026