Levetiracetam Oral Solution (Lannett) – Microbial Contamination (2019)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
Brand
Lannett Company, Inc.
Lot Codes / Batch Numbers
Lot #: 2190A, 2191A, Exp. Date 07/2021
Products Sold
Lot #: 2190A, 2191A, Exp. Date 07/2021
Lannett Company, Inc. is recalling Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett due to Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026