Lidocaine Hydroclhoride Jelly USP — Class II drug recall D-1878-2019
Terminated recall by Akorn, Inc., reported 2019-10-02, distributed nationwide. cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder durin
| Recall number | D-1878-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2019-09-17 |
| Classified | 2019-09-24 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2022-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 10,543 tubes |
| Reason classes | cgmp, specification failure |
| NDC | 17478-0711-30 |
| Lot numbers | 9B21A |
| Expiration dates | 2022-01 |
Product
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Reason for recall
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
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-1878-2019. 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.