PFIZER, INC recalls 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC
Pfizer recalls 30mL single-dose vials of 0.5% Bupivacaine Hydrochloride Injection that may contain lidocaine instead. This labeling mix-up could lead to incorrect medication use during medical procedures.
Lower-risk 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
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling 30mL single-dose vials of 0.5% Bupivacaine Hydrochloride Injection due to a labeling mix-up. Some vials labeled as containing bupivacaine may actually contain lidocaine, and vice versa. This could lead to incorrect medication administration during medical procedures. Read more at govinfonow.com/recall/36159-pfizer-0-5-bupivacaine-vials-may-contain-wrong-medication.
Source Summary by GovInfoNow · govinfonow.com/recall/36159-pfizer-0-5-bupivacaine-vials-may-contain-wrong-medication · Updated October 4, 2026 · FDA enforcement record: FDA #D-0626-2021
Cite this page
“Pfizer 0.5% Bupivacaine Vials May Contain Wrong Medication.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36159-pfizer-0-5-bupivacaine-vials-may-contain-wrong-medication. Based on FDA recall #D-0626-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0626-2021%22&limit=1).
Why it’s dangerous
The vials have been mislabeled, meaning some vials marked as 0.5% Bupivacaine Hydrochloride Injection may contain 1% Lidocaine HCl Injection instead. This could lead to incorrect medication administration during procedures requiring precise drug concentrations.
Who’s affected
Patients receiving injections from healthcare providers who use these vials. Healthcare professionals administering the medication are most at risk of giving the wrong drug.
How to tell if you have this one
Check for vials labeled as '0.5% Bupivacaine Hydrochloride Injection, USP' that may contain lidocaine. The vials have NDC 0409-1162-19 and were packaged in 25 per tray (NDC 0409-1162-02).
- Brand
Pfizer- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide in the USA, Puerto Rico, and Guam
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0626-2021 | 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.; Lot EG6023, Exp. 07/01/2022 | 163,957 vials | 0409-1159-18, 0409-1159-01, 0409-1159-19, 0409-1159-02, 0409-1160-18, 0409-1160-01, 0409-1162-18, 0409-1162-01, 0409-1162-19, 0409-1162-02, 0409-1163-18, 0409-1163-01, 0409-1165-18, 0409-1165-01, 0409-1165-19, 0409-1165-02, 0409-9043-11, 0409-9043-01, 0409-9046-11, 0409-9046-01, 0409-9045-11, 0409-9045-01, 0409-9045-16, 0409-9045-17, 0409-9042-11, 0409-9042-01, 0409-9042-16, 0409-9042-17 |
| D-0627-2021 | 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.; Lot EG8933, Exp. 08/01/2022 | 139,050 vials | 0409-4713-12, 0409-4713-26, 0409-4713-02, 0409-4713-72, 0409-4713-62, 0409-4713-75, 0409-4713-65, 0409-4713-42, 0409-4713-25, 0409-4713-32, 0409-4278-16, 0409-4278-01, 0409-4279-16, 0409-4279-02, 0409-4776-10, 0409-4776-01, 0409-4282-11, 0409-4282-25, 0409-4282-01, 0409-4282-12, 0409-4282-02, 0409-4277-16, 0409-4277-01, 0409-4277-17, 0409-4277-02, 0409-4276-16, 0409-4276-01, 0409-4276-17, 0409-4276-02, 0409-4275-16, 0409-4275-01 |
What to do — step by step
Check Vial Label
Verify the label on the vial to ensure it matches the intended medication. If the label shows 0.5% Bupivacaine Hydrochloride Injection, USP, it may contain lidocaine instead.
Questions people ask
What is the specific product being recalled?
Pfizer's 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19).
How can I tell if I have the recalled vials?
Look for vials labeled as '0.5% Bupivacaine Hydrochloride Injection, USP' that may contain lidocaine instead. They have NDC 0409-1162-19 and were packaged in 25 per tray (NDC 0409-1162-02).
What should I do if I have the recalled vials?
The recall does not specify a remedy, so check the label to ensure it matches the intended medication. Contact your healthcare provider if you have concerns.
Contact Pfizer
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0626-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0626-2021 from Pfizer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0626-2021 (May 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0626-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.