Stop using now Drug recall · FDA · Published May 20, 2024

Pfizer Recalls Labetalol Injection Due to Sterility Risk

Pfizer recalls specific lots of Labetalol Hydrochloride Injection due to potential incomplete crimp seals and lack of sterility assurance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0565-2024Drug Pfizer ›

Stop using this now

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Take action

Contact the company

Recalling firmPfizer Inc.235 East 42nd Street · New York, NY 10017-5703

✎ GovInfoNow plain-language explainer

Pfizer Inc. is recalling Labetalol Hydrochloride Injection, USP, 20 mg/4 mL distributed by Hospira, Inc. The recall addresses a potential for incomplete crimp seals on the single-dose Carpuject cartridges. This defect raises concerns about the assurance of sterility for these sterile cartridge units. Read more at govinfonow.com/recall/32660-pfizer-recalls-labetalol-injection-due-to-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32660-pfizer-recalls-labetalol-injection-due-to-sterility-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0565-2024

Cite this page

“Pfizer Recalls Labetalol Injection Due to Sterility Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32660-pfizer-recalls-labetalol-injection-due-to-sterility-risk. Based on FDA recall #D-0565-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0565-2024%22&limit=1).

Pfizer Inc. recalled Labetalol Hydrochloride Injection, USP, 20 mg/4 mL due to lack of sterility assurance from potential incomplete crimp seals, the FDA said on May 20, 2024.

How to tell if you have it

Brand: Pfizer
Product: Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock
NDC: 0409-2339-24
Lot#: HJ7566; Exp 2025/05
Lot#: HN8747; Exp 2025/09
Lot#: HN8749; Exp 2025/09
Quantity: 220,400 cartridges

The hazard

The recall addresses the potential for incomplete crimp seals leading to a lack of assurance of sterility in the injection product.

Context

GovInfoNow's records show Pfizer Inc. has 71 other recalls on record since November 26, 2012. Other recent recalls include a Sodium Bicarbonate Injection recall for lack of sterility assurance on August 4, 2025, and a Bicillin L-A Injectable Suspension recall for particulate risk on July 10, 2025. Similar recent recalls of similar products include a Dopamine HCl Inj Recall for lack of sterility risk on September 4, 2026, and a Lanreotide Injection Recall for contamination due to sterility issues on March 13, 2026.

How to tell if you have this one

Check if you have Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock. Verify the NDC 0409-2339-24 and look for one of these lot numbers: HJ7566 (Exp 2025/05), HN8747 (Exp 2025/09), or HN8749 (Exp 2025/09). The product was distributed nationwide in the US and Puerto Rico.

Brand
Pfizer
Category
Drug

FDA recall event · 2 products

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

Based on the official FDA remedy

What to do — step by step

Stop Using Affected Lots
Do not use any Labetalol Hydrochloride Injection cartridges with lot numbers HJ7566, HN8747, or HN8749 due to sterility concerns.
Contact Healthcare Provider
Inform your healthcare provider if you have received or used any of the recalled lots so they can assess potential risks and provide alternative treatment.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 44 days after the firm started it.

May 20, 2024Firm started the recall
Jun 22, 2024FDA classified it Class II
Jul 3, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32660-pfizer-recalls-labetalol-injection-due-to-sterility-risk">Pfizer Recalls Labetalol Injection Due to Sterility Risk (GovInfoNow)</a>

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 qwen3.6:35b-a3b on October 9, 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.