1% LIDOCAINE HCl Injection — Class I drug recall D-0382-2015
Terminated recall by Hospira Inc., reported 2015-02-11, distributed nationwide. Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as
| Recall number | D-0382-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-04-18 |
| Classified | 2015-01-30 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2017-11-07 |
| Distributed | Nationwide (US) |
| Quantity | 120,900 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-4275, 00409-4275-01, 00409-4275-16, 00409-4276, 00409-4276-01, 00409-4276-02, 00409-4276-16, 00409-4276-17, 00409-4277, 00409-4277-01, 00409-4277-02, 00409-4277-16, 00409-4277-17, 00409-4278, 00409-4278-01, 00409-4278-16, 00409-4279, 00409-4279-02, 00409-4279-16, 00409-4282, 00409-4282-01, 00409-4282-02, 00409-4282-11, 00409-4282-12, 00409-4282-25 and 14 more |
| Lot numbers | 31-427-DK |
| Expiration dates | 2015-07-01 |
Product
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
Reason for recall
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
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-0382-2015. 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.