Nephron PF-Labetalol HCl Injection Recall: Cross Contamination Risk

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Contact the company & request your remedy

Recalling firmNephron Sterile Compounding Center LLC4500 12th Street Ext, N/A · West Columbia, SC 29172-3025

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Nephron is recalling certain labetalol injection vials that may have cross contamination risks. This affects patients using these medications under prescription.

Why it’s dangerous

The manufacturing process may have caused cross contamination between vials due to product carry over. This could lead to unintended medication mix-ups.

Who’s affected

Prescription patients using the recalled labetalol injection vials. Healthcare providers who dispense these medications are most at risk.

How to tell if you have this one

Check for the Nephron 503B Outsourcing Facility vials labeled with NDC 69374-946-34. The vials were produced in lots LB2001B (expiring 01/07/2023) and LB2005B (expiring 03/02/2023).

Brand
Nephron
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Vial Label
Look for the NDC code 69374-946-34 on the vial label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is for potential cross contamination risk, but the product is safe if used properly with the correct vial.

How can I tell if I have the recalled vial?

Check for the NDC code 69374-946-34 and lots LB2001B or LB2005B with expiration dates 01/07/2023 or 03/02/2023.

Do I need to stop using this product?

No, but you should check if you have the recalled vials and contact your healthcare provider if you're unsure.

Take action

Contact Nephron

We’ve drafted a message you can send Nephron to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0064-2023 — Nephron Nephron

Hello,

I own a Nephron that is covered by recall D-0064-2023 from Nephron.

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-0064-2023 (November 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0064-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Nephron Sterile Compounding Center LLC recalls PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street

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