Marcaine — Class I drug recall D-1161-2014
Terminated recall by Hospira Inc., reported 2014-03-26, distributed nationwide. Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in
| Recall number | D-1161-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-10-18 |
| Classified | 2014-03-14 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2015-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 40,360 vials |
| Reason classes | 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 | 25-220-DD |
| Expiration dates | 2015-01-01 |
Product
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Reason for recall
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
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-1161-2014. 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.