Lidocaine Hydrochloride Jelly USP — Class II drug recall D-0143-2023
Ongoing recall by Akorn, Inc., reported 2023-01-25, distributed nationwide. CGMP Deviations:
| Recall number | D-0143-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Gurnee, IL, United States |
| Recall initiated | 2022-10-13 |
| Classified | 2023-01-13 |
| Reported by FDA | 2023-01-25 |
| Distributed | Nationwide (US) |
| Quantity | 2,369,258 tubes |
| Reason classes | cgmp |
| NDC | 17478-0711-10, 17478-0711-30, 17478-0711-31 |
| Lot numbers | 0A02A, 0A02B, 0A02C, 0A02D, 0A02E, 0A06A, 0A37A, 0B44A, 0B46A, 0B46B, 0B46D, 0B60A, 0B60B, 0B60C, 0B60D, 0B67A, 0B67B, 0B67C, 0B67D, 0C78B, 0C78C, 0C78D, 0C84A, 0C88A, 0D08A, 0D11A, 0D11B, 0D11C, 0D11D, 0D21A, 0E31A, 0E35A, 0E35B, 0E35C, 0E46A, 0E46B, 0E48A, 0F58A, 0F72A, 0G05A and 69 more |
| Expiration dates | 2022-12-31, 2023-01-31, 2023-02-28, 2023-03-31, 2023-04-30, 2023-05-31, 2023-06-30, 2023-07-31, 2023-08-31, 2023-09-30, 2023-10-31, 2024-01-31, 2024-02-29, 2024-03-31, 2024-06-30, 2024-07-31, 2024-08-31, 2024-09-30, 2024-10-31, 2025-02-28, 2025-03-31 |
Product
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
Reason for recall
CGMP Deviations:
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-0143-2023. 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.