Bupivacaine HCl Inj — Class II drug recall D-1588-2014
Terminated recall by Hospira Inc., reported 2014-09-24, distributed nationwide. Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored
| Recall number | D-1588-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-09-04 |
| Classified | 2014-09-17 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 75,000 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-1159, 00409-1159-01, 00409-1159-02, 00409-1159-18, 00409-1159-19, 00409-1160, 00409-1160-01, 00409-1160-18, 00409-1162, 00409-1162-01, 00409-1162-02, 00409-1162-18, 00409-1162-19, 00409-1163, 00409-1163-01, 00409-1163-18, 00409-1165, 00409-1165-01, 00409-1165-02, 00409-1165-18, 00409-1165-19, 00409-9042, 00409-9042-01, 00409-9042-11, 00409-9042-16 and 12 more |
| Lot numbers | 37-268-DK |
| Expiration dates | 2016-01-01 |
Product
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02
Reason for recall
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
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-1588-2014. 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.