FDA Drug recall D-0397-2019
Lidocaine gel 2%, RX, plastic dropper
- FDA Drug
- Class II
- terminated
- Published 2019-01-09
On 2019-01-09 the FDA classified a Class II recall of Lidocaine gel 2%, RX, plastic dropper by Hiers Enterprises, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0397-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-02 |
| Published | 2019-01-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hiers Enterprises |
| Distribution | OR |
Product
Lidocaine gel 2%, RX, plastic dropper
Reason
Lack of sterility assurance.
Identifiers
| code_info | 10222018@15 |
|---|
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-0397-2019%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.