FDA Drug recall D-0221-2021
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701
- FDA Drug
- Class II
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701 by Akorn, citing defective container: Customer complaints for oral solution leaking from bottles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0221-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-28 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Defective container: Customer complaints for oral solution leaking from bottles.
Identifiers
| code_info | Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022 |
|---|
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-0221-2021%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.