Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I · High risk Terminated Initiated Oct 23, 2023 (3 years ago)

Phenytoin Oral Suspension

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Failed Content Uniformity Specifications

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

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

Affected NDCs 0904-7079-24 0904-7079-57

Compare with the code on your package — it is the most precise check available.

Drug: Phenytoin

Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
NDC code
0904-7079-24
Origin
TN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0153-2024 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Phenytoin recalls

See all
Class II · Moderate risk

Extended Phenytoin Sodium Capsules

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Terminated Dissolution failure Amneal Pharmaceuticals of New York, LLC NDC 65162-212-10 D-0876-2023
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.

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-05 D-0070-2023
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.

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-02 D-0069-2023
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.

Terminated Failed specification Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4069-1 D-0863-2020

Other recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

All 2023 recalls
Class II · Moderate risk

Omega-3-Acid

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

Ongoing Failed specification The Harvard Drug Group LLC D-0493-2026