Levetiracetam recalls
The FDA has published 16 recalls involving Levetiracetam since 2012. The latest was reported on 23 Apr 2025. Most were for packaging defects. AuroMedics Pharma 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 16 since 2012
Last 12 months 0 reported
Class I 3 19% of total
Ongoing 2 latest 23 Apr 2025
Recalls per month, last 24 months click a bar for that month Severity split
3 19%11 69%2 13%
Why levetiracetam is recalled
Ongoing levetiracetam recalls 2 active
All levetiracetam recalls, newest first 16 total Reported Class Recall Company Reason Where 23 Apr 2025 Drug CLASS I Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalled Levetiracetam Dr. Reddy's Laboratories Labeling Errors Nationwide 7 Jun 2023 Drug CLASS II Levetiracetam Oral Solution 100 mg/mL (100 mg/mL) recalled by Akorn Akorn Potency & Assay Nationwide 16 Jun 2021 Drug CLASS III Levetiracetam Tablets USP, 250 mg UD recalled by McKesson McKesson Other Nationwide 20 Jan 2021 Drug CLASS II Levetiracetam Oral Solution, 100 mg/mL recalled by Akorn Akorn Packaging Defects Nationwide 2 Dec 2020 Drug CLASS II Levetiracetam Tablets, USP 500 mg recalled by Eywa Pharma Eywa Pharma Packaging Defects Nationwide 22 Apr 2020 Drug CLASS II Levetiracetam Tablets USP 750 mg recalled by Aurobindo Pharma USA Levetiracetam Aurobindo Pharma USA Manufacturing (CGMP) Deviations Nationwide 25 Dec 2019 Drug CLASS I Levetiracetam Oral Solution 100mg/mL recalled by Lannett Company Lannett Sterility Nationwide 27 Nov 2019 Drug CLASS III Levetiracetam Injection, 500 mg/-use vials recalled X-Gen Pharmaceuticals Packaging Defects Nationwide 31 Jul 2019 Drug CLASS II Keppra (levetiracetam) recalled by Ucb Keppra Ucb Potency & Assay TN 20 Feb 2019 Drug CLASS I Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg recalled Levetiracetam Dr. Reddy's Laboratories Other Nationwide 9 May 2018 Drug CLASS II Levetiracetam in 0.75% Sodium Chloride Injection recalled Levetiracetam AuroMedics Pharma Mold Nationwide 9 May 2018 Drug CLASS II Levetiracetam in 0.82% Sodium Chloride Injection recalled Levetiracetam AuroMedics Pharma Mold Nationwide 9 May 2018 Drug CLASS II Levetiracetam in 0.54% Sodium Chloride Injection recalled Levetiracetam AuroMedics Pharma Mold Nationwide 6 Dec 2017 Drug CLASS II Levetiracetam Oral Solution, USP, 100 mg/mL recalled Levetiracetam Hetero Labs Ltd. - Unit III Packaging Defects NJ 18 Feb 2015 Drug CLASS II Levetiracetam, extended release tablets, 750 mg recalled Sun Pharma Global Fze Potency & Assay Nationwide 3 Oct 2012 Drug CLASS II Levetiracetam Tablets, USP 500 mg recalled by Mylan Pharmaceuticals Levetiracetam Mylan Pharmaceuticals Other KY
Should you stop taking Levetiracetam?
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.