Marcaine — Class I drug recall D-0002-2015
Terminated recall by Hospira Inc., reported 2014-10-08, distributed nationwide. Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particl
| Recall number | D-0002-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-06-17 |
| Classified | 2014-10-01 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2017-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 40,730 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-0525, 00409-0525-01, 00409-0525-25, 00409-1250, 00409-1250-01, 00409-1250-25, 00409-1530, 00409-1530-01, 00409-1530-25, 00409-1559, 00409-1559-10, 00409-1559-18, 00409-1559-19, 00409-1559-30, 00409-1560, 00409-1560-10, 00409-1560-18, 00409-1560-19, 00409-1560-29, 00409-1582, 00409-1582-10, 00409-1582-18, 00409-1582-19, 00409-1582-29, 00409-1587 and 32 more |
| Lot numbers | 09/15, 33-545-DD |
Product
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29
Reason for recall
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the 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-0002-2015. 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.