Phenytoin recalls
The FDA has published 10 recalls involving Phenytoin since 2013. The latest was reported on 27 Dec 2023. Most were for potency & assay. Amneal Pharmaceuticals of New York has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 10 since 2013
Last 12 months 0 reported
Class I 2 20% of total
Ongoing 0 latest 27 Dec 2023
Recalls per month, last 24 months click a bar for that month Severity split
2 20%6 60%2 20%
Why phenytoin is recalled
All phenytoin recalls, newest first 10 total Reported Class Recall Company Reason Where 27 Dec 2023 Drug CLASS I Phenytoin Oral Suspension, USP, 100 mg recalled The Harvard Drug Group Packaging Defects Nationwide 15 Nov 2023 Drug CLASS II Extended Phenytoin Sodium Capsules, USP, 100 mg recalled Extended Phenytoin Sodium Amneal Pharmaceuticals of New York Potency & Assay Nationwide 21 Jun 2023 Drug CLASS II Extended Phenytoin Sodium Capsules, USP, 100 mg recalled Extended Phenytoin Sodium Amneal Pharmaceuticals of New York Potency & Assay LA, OH, PA 30 Nov 2022 Drug CLASS III Phenytoin Sodium Injection, USP 100 mg recalled Phenytoin Sodium Acella Pharmaceuticals Packaging Defects Nationwide 30 Nov 2022 Drug CLASS III Phenytoin Sodium Injection, USP, 250 mg recalled Phenytoin Sodium Acella Pharmaceuticals Packaging Defects Nationwide 4 Mar 2020 Drug CLASS I Phenytoin Oral Suspension USP, 125 mg/ potency recalled Phenytoin Taro Pharmaceuticals U Potency & Assay Nationwide 8 Feb 2017 Drug CLASS II Phenytoin Oral Suspension, USP 100 mg/ dose cups recalled by VistaPharm VistaPharm Sterility Nationwide 29 Jan 2014 Drug CLASS II Phenytoin Sodium ER, Capsule, 30 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 18 Dec 2013 Drug CLASS II Phenytoin Oral Suspension USP 125mg/, For Oral Administration Only recalled VistaPharm Potency & Assay Nationwide 13 Nov 2013 Drug CLASS II Extended Phenytoin Sodium Capsules, USP, 100 mg recalled Extended Phenytoin Sodium Amneal Pharmaceuticals of New York Potency & Assay 7 states
Should you stop taking Phenytoin?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.