Levetiracetam Oral Solution 100mg/mL — Class I drug recall D-0630-2020
Terminated recall by Lannett Company, Inc., reported 2019-12-25, distributed nationwide. Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Micro
| Recall number | D-0630-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2019-12-06 |
| Classified | 2019-12-27 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2020-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 16,668 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 54838-0548-80 |
| Lot numbers | 2190A, 2191A |
| Expiration dates | 2021-07 |
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 for recall
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0630-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.