Lidocaine Hydrochloride Jelly USP — Class II drug recall D-1495-2022
Terminated recall by Akorn, Inc., reported 2022-09-14, distributed nationwide. cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to
| Recall number | D-1495-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Gurnee, IL, United States |
| Recall initiated | 2022-08-31 |
| Classified | 2022-09-06 |
| Reported by FDA | 2022-09-14 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 82,689 tubes |
| Reason classes | sterility, cgmp |
| NDC | 17478-0711-31 |
| Lot numbers | 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, 9K62A, 9K62B, 9K62C, 9M04A, 9M04B |
| Expiration dates | 2022-08-31, 2022-09-30, 2022-11-30 |
Product
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Reason for recall
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
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-1495-2022. 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.