FDA Drug recall D-0846-2022
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc
- FDA Drug
- Class III
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class III recall of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc by Akorn, citing failed viscosity specification - product was below specificcation.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0846-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-04-15 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04
Reason
Failed viscosity specification - product was below specificcation
Identifiers
| code_info | Lot #: 370978, Exp 9/30/2022 |
|---|
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-0846-2022%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.