Lidocaine 2 — Class II drug recall D-1046-2018
Terminated recall by Akorn, Inc., reported 2018-08-15, distributed nationwide. Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found d
| Recall number | D-1046-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2018-08-01 |
| Classified | 2018-08-07 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2020-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 22,605 tubes |
| Reason classes | specification failure |
| NDC | 50383-0667-30 |
| Lot numbers | 356309 |
| Expiration dates | 2019-03 |
Product
Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
Reason for recall
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
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-1046-2018. 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.