Lidocaine Hydrochloride Oral Topical Solution — Class III drug recall D-0846-2022
Terminated recall by Akorn, Inc., reported 2022-05-11, distributed nationwide. Failed viscosity specification - product was below specificcation
| Recall number | D-0846-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2022-04-15 |
| Classified | 2022-05-05 |
| Reported by FDA | 2022-05-11 |
| Terminated | 2023-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 66,744 bottles |
| NDC | 50383-0775-04 |
| Lot numbers | 370978 |
| Expiration dates | 2022-09-30 |
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 for recall
Failed viscosity specification - product was below specificcation
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-0846-2022. 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.