Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications
Is Phenytoin recalled?
Not under an active recall.
Phenytoin was recalled 15 times in the past — all now closed. Most recent: Oct 27, 2023.
Most common reason: Dissolution failure (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenytoin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Phenytoin recalls on record
none so far in 2026; 15 on record, newest first
Class I · High risk
Phenytoin Oral Suspension
Failed Content Uniformity Specifications
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class I · High risk
Phenytoin Oral Suspension USP
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Class II · Moderate risk
Phenytoin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk
Phenytoin Oral Suspension USP 125mg/5mL
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed dissolution specifications; 18 month CRT
Class II · Moderate risk
Phenytoin Sodium ER
Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W003327, EXP: 6/19/2014.
Class II · Moderate risk
Xactdose Phenytoin Oral Suspension
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Class II · Moderate risk
Xactdose Phenytoin Oral Suspension
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
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