FDA Drug recall D-0143-2023

Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31

FDA Drug
Class II
ongoing
Published 2023-01-25

On 2023-01-25 the FDA classified a Class II recall of Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31 by Akorn, citing CGMP Deviations:.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0143-2023
Classification	Class II
Status	ongoing
Initiated	2022-10-13
Published	2023-01-25
Last updated	2026-09-13 11:52 UTC
Company	Akorn
Distribution	US

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

CGMP Deviations:

Identifiers

code_info	Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B6… Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023; 0C78B, 0C78D, 0C78C, EXP 2/28/2023; 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023; 0J63B, 0J63C, EXP 8/31/2023; 0K02A, 0K02C, 0K02D, 0K02B, EXP 9/30/2023; 0L47B, 0L47C, 0L47A, EXP 10/31/2023; 1B12B, 1B12A, 1B23A, 1B23F, 1B12C, 1B23B, 1B23D, 1B23E, 1B12D, EXP 1/31/2024; 1C66C, 1C66A, EXP 2/29/2024; 1D93B, 1D93D, 1D93C, 1D99B, 1D99C, 1D99A, 1D93A, 1D99D, EXP 3/31/2024 1H96C, 1H96D, 1H96E, EXP 7/31/2024; 1J37B, 1J47B, 1J47D, 1J37C, 1J37A, 1J47C, EXP 8/31/2024; 1L18D, 1L98C, 1L18C, 1L18A, 1L98B, 1L98D, 1L18B, 1L98E, EXP 10/31/2024; 2D21B, EXP 3/31/2025 (b) 0A06A, 0A37A , EXP 12/31/2022; 0B44A, EXP 1/31/2023; 0C88A, 0C84A, EXP 2/28/2023; 0D21A, 0D08A, EXP 3/31/2023; 0E46A, 0E46B, 0E31A, 0E48A, EXP 4/30/2023; 0F72A, 0F58A, EXP 5/31/2023; 0G05A, EXP 6/30/2023; 0H41A, EXP 7/31/2023; 0J67A, 0J67B, E

code_info

Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B6…

Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023; 0C78B, 0C78D, 0C78C, EXP 2/28/2023; 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023; 0J63B, 0J63C, EXP 8/31/2023; 0K02A, 0K02C, 0K02D, 0K02B, EXP 9/30/2023; 0L47B, 0L47C, 0L47A, EXP 10/31/2023; 1B12B, 1B12A, 1B23A, 1B23F, 1B12C, 1B23B, 1B23D, 1B23E, 1B12D, EXP 1/31/2024; 1C66C, 1C66A, EXP 2/29/2024; 1D93B, 1D93D, 1D93C, 1D99B, 1D99C, 1D99A, 1D93A, 1D99D, EXP 3/31/2024 1H96C, 1H96D, 1H96E, EXP 7/31/2024; 1J37B, 1J47B, 1J47D, 1J37C, 1J37A, 1J47C, EXP 8/31/2024; 1L18D, 1L98C, 1L18C, 1L18A, 1L98B, 1L98D, 1L18B, 1L98E, EXP 10/31/2024; 2D21B, EXP 3/31/2025 (b) 0A06A, 0A37A , EXP 12/31/2022; 0B44A, EXP 1/31/2023; 0C88A, 0C84A, EXP 2/28/2023; 0D21A, 0D08A, EXP 3/31/2023; 0E46A, 0E46B, 0E31A, 0E48A, EXP 4/30/2023; 0F72A, 0F58A, EXP 5/31/2023; 0G05A, EXP 6/30/2023; 0H41A, EXP 7/31/2023; 0J67A, 0J67B, E

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0143-2023%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.