0 — Class I drug recall D-0626-2021
Terminated recall by PFIZER, INC, reported 2021-06-09, distributed nationwide. Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contai
| Recall number | D-0626-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PFIZER, INC, Lake Forest, IL, United States |
| Recall initiated | 2021-05-03 |
| Classified | 2021-06-10 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2023-04-04 |
| Distributed | Nationwide (US) |
| Quantity | 163,957 vials |
| Reason classes | labeling |
| 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 | EG6023 |
| Expiration dates | 2022-07-01 |
Product
0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Reason for recall
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
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-0626-2021. 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.