1% Lidocaine HCl Injection — Class I drug recall D-0627-2021
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-0627-2021 |
|---|---|
| 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 | 139,050 vials |
| Reason classes | labeling |
| NDC | 00409-4275, 00409-4275-01, 00409-4275-16, 00409-4276, 00409-4276-01, 00409-4276-02, 00409-4276-16, 00409-4276-17, 00409-4277, 00409-4277-01, 00409-4277-02, 00409-4277-16, 00409-4277-17, 00409-4278, 00409-4278-01, 00409-4278-16, 00409-4279, 00409-4279-02, 00409-4279-16, 00409-4282, 00409-4282-01, 00409-4282-02, 00409-4282-11, 00409-4282-12, 00409-4282-25 and 14 more |
| Lot numbers | EG8933 |
| Expiration dates | 2022-08-01 |
Product
1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), 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-0627-2021. 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.