Phenytoin Oral Suspension (VistaPharm) – defective container (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
Brand
VistaPharm, Inc.
Lot Codes / Batch Numbers
Lots #'s: 268200, Exp 06/14, 274600, Exp 08/14, 279500, Exp 09/14, 290700, Exp 12/14, 296700, Exp 02/15, 305100, Exp 06/15
Products Sold
Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15
VistaPharm, Inc. is recalling Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, M due to Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability. 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
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
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 10, 2026