RecallRadar

FDA Drug recall D-0630-2020

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc

On 2019-12-25 the FDA classified a Class I recall of Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc by Lannett, citing microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0630-2020
ClassificationClass I
Statusterminated
Initiated2019-12-06
Published2019-12-25
Last updated2026-09-13 11:52 UTC
CompanyLannett
DistributionUS

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

Reason

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

Identifiers

code_infoLot #: 2190A, 2191A, Exp. Date 07/2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0630-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.