Levetiracetam recalls

Levetiracetam products have been recalled 9 times, most recently on 23 Apr 2025. The recalling company is usually AuroMedics Pharma. The most common reason is mold.

Total recalls9since 2012

Last 12 months0reported

Class I222% of total

Ongoing1latest 23 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 22%Class II 6 67%Class III 1 11%

Why levetiracetam is recalled

Companies

Product types

Injectable & IV Drugs667%
Seizure Medication333%

By year

2025111%
2020111%
2019222%
2018333%
2017111%
2012111%

Ongoing levetiracetam recalls

1 active

Reported	Class	Recall	Company	Reason	Where
23 Apr 2025Drug	CLASS I	Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam	Dr. Reddy's Laboratories	Labeling Errors	Nationwide

All levetiracetam recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
23 Apr 2025Drug	CLASS I	Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam	Dr. Reddy's Laboratories	Labeling Errors	Nationwide
22 Apr 2020Drug	CLASS II	Levetiracetam Tablets USP 750 mg recalled by Aurobindo Pharma USALevetiracetam	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
27 Nov 2019Drug	CLASS III	Levetiracetam Injection, 500 mg/-use vials recalledLevetiracetam	X-Gen Pharmaceuticals	Packaging Defects	Nationwide
20 Feb 2019Drug	CLASS I	Levetiracetam in 54 % Sodium Chloride Injection 1,500/mg recalledLevetiracetam	Dr. Reddy's Laboratories	Other	Nationwide
9 May 2018Drug	CLASS II	Levetiracetam in 75% Sodium Chloride Injection, 1000 mg recalledLevetiracetam	AuroMedics Pharma	Mold	Nationwide
9 May 2018Drug	CLASS II	Levetiracetam in 82% Sodium Chloride Injection, 500 mg recalledLevetiracetam	AuroMedics Pharma	Mold	Nationwide
9 May 2018Drug	CLASS II	Levetiracetam in 54% Sodium Chloride Injection recalledLevetiracetam	AuroMedics Pharma	Mold	Nationwide
6 Dec 2017Drug	CLASS II	Levetiracetam Oral Solution, USP, 100 mg/mL recalledLevetiracetam	Hetero Labs, Ltd. - Unit III	Packaging Defects	NJ
3 Oct 2012Drug	CLASS II	Levetiracetam Tablets, USP 500 mg recalled by Mylan PharmaceuticalsLevetiracetam	Mylan Pharmaceuticals	Other	KY

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.