Bupivacaine Hydrochloride Inj — Class I drug recall D-0218-2017
Ongoing recall by Hospira Inc., A Pfizer Company, reported 2016-12-28, distributed nationwide. Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a sing
| Recall number | D-0218-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., A Pfizer Company, Lake Forest, IL, United States |
| Recall initiated | 2016-08-04 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 143,250 vials |
| Reason classes | 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 | 11/17, 59064DK |
Product
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Reason for recall
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single 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-0218-2017. 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.