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

Recall Insight

This FDA Drug action (record #D-0630-2020) was formally reported on December 25, 2019, with the manufacturer initiating the action on December 6, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Lannett Company, Inc. is listed as the recalling firm, operating out of Philadelphia, PA. Federal records indicate 16,668 bottles units are affected.

The documented reason for this recall is: Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count. Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.