Levetiracetam Oral Solution — Class II drug recall D-0221-2021
Terminated recall by Akorn, Inc., reported 2021-01-20, distributed nationwide. Defective container: Customer complaints for oral solution leaking from bottles.
| Recall number | D-0221-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2020-12-28 |
| Classified | 2021-01-11 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2022-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 22,248 bottles |
| Reason classes | packaging |
| NDC | 50383-0241-16 |
| Lot numbers | 373859, 373863, 373865, 374586 |
| Expiration dates | 2022-05, 2022-06 |
Product
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
Reason for recall
Defective container: Customer complaints for oral solution leaking from bottles.
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-0221-2021. 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.