Marcaine 0 — Class II drug recall D-0097-2017
Terminated recall by Hospira Inc., A Pfizer Company, reported 2016-10-19, distributed nationwide. Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal
| Recall number | D-0097-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., A Pfizer Company, Lake Forest, IL, United States |
| Recall initiated | 2016-09-16 |
| Classified | 2016-10-13 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2019-07-31 |
| Distributed | Nationwide (US) |
| Quantity | 4,768 vials |
| Reason classes | foreign material, labeling, potency, sterility, packaging |
| 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 | 59310DD |
| Expiration dates | 2017-11-01 |
Product
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Reason for recall
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
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-0097-2017. 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.