Pfizer Inc. recalls Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with
Pfizer recalls certain Labetalol Hydrochloride Injection units due to potential incomplete crimp seals that could cause contamination. Affected lots expire in 2025 and are for IV use only.
Recall notice
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling specific Labetalol Hydrochloride Injection products that may have incomplete crimp seals, which could lead to contamination. This recall affects patients using these injections for medical treatment. Read more at govinfonow.com/recall/32660-pfizer-labetalol-injection-recall-risk-of-contamination-from-incomplete-crimp.
Source Summary by GovInfoNow · govinfonow.com/recall/32660-pfizer-labetalol-injection-recall-risk-of-contamination-from-incomplete-crimp · Updated September 23, 2026 · FDA enforcement record: FDA #D-0565-2024
Cite this page
“Pfizer Labetalol Injection Recall: Risk of Contamination from Incomplete Crimp Seals.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32660-pfizer-labetalol-injection-recall-risk-of-contamination-from-incomplete-crimp. Based on FDA recall #D-0565-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0565-2024%22&limit=1).
Why it’s dangerous
The product may have incomplete crimp seals that could allow contamination. This is a potential risk during injection use, though the exact mechanism of harm is not specified in the recall notice.
Who’s affected
Patients prescribed Labetalol Hydrochloride Injection by a healthcare provider. Those using the recalled product for intravenous treatment are most at risk.
How to tell if you have this one
Check the product label for the NDC code 0409-2339-24. The affected lots are HJ7566 (expiring May 2025) and HN8747, HN8749 (both expiring September 2025).
- 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 II- Status
Ongoing- Distribution
US Nationwide and Puerto Rico.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0564-2024 | Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03; Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10 | 84,710 cartridges | 0409-2012-03, 0409-2012-32 |
| D-0565-2024 | Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24; Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09 | 220,400 cartridges | 0409-2339-24, 0409-2339-34 |
What to do — step by step
Check Product Label
Look for the NDC code 0409-2339-24 on the product label.
Questions people ask
Is this product safe to use?
The recall does not state that the product is safe to use; it indicates a potential risk of contamination due to incomplete crimp seals.
What should I do if I have this product?
The recall does not specify a remedy; you should check the product label for the NDC code and lot numbers to determine if it is affected.
How can I get a replacement?
The recall does not mention any replacement or remedy steps.
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-0565-2024 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0565-2024 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-0565-2024 (May 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0565-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.