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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Hospira Inc. A Pfizer Company: Labetalol Hydrochloride Injection Recalled for Cracked Glass Vials

Agency Publication Date: March 2, 2018
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Summary

Hospira Inc., a Pfizer company, is recalling approximately 178,118 vials of Labetalol Hydrochloride Injection, USP (100 mg/20 mL), which is used to treat high blood pressure. The recall was initiated because of a defect where the glass at the rim of the vials may be cracked, though the damage is hidden by the stopper and seal. This affects both Hospira-branded and NOVAPLUS-branded vials distributed nationwide across the United States and Puerto Rico. Consumers should check their medication supply immediately and consult with their healthcare provider if they have been using these specific lots.

Risk

A cracked glass rim can compromise the sterile seal of the vial, potentially allowing bacteria or other contaminants to enter the medication. If contaminated medication is injected, it could lead to serious infections or other health complications.

What You Should Do

  1. Identify if you have the affected medication by checking the brand name and NDC number on the label: Hospira, Inc. (NDC 0409-2267-20) or NOVAPLUS (NDC 0409-2267-25).
  2. Check the vial for the following lot numbers and expiration dates: for Hospira-branded vials, look for lot 74370DD (Exp 1FEB2019), 75035DD (Exp 1MAR2019), or 75115DD (Exp 1MAR2019); for NOVAPLUS-branded vials, look for lot 74230DD (Exp 1FEB2019).
  3. If you have an affected vial, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.
  4. Return any unused, recalled vials to the pharmacy or place of purchase for a refund.
  5. Contact the manufacturer, Hospira Inc. (a Pfizer Company), if you have further questions regarding the return process.
  6. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial (Hospira Brand)
Model:
NDC 0409-2267-20
D-0576-2018
Lot Numbers:
74370DD (Exp 1FEB2019)
75035DD (Exp 1MAR2019)
75115DD (Exp 1MAR2019)
Date Ranges: 1FEB2019, 1MAR2019
Product: Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial (NOVAPLUS Brand)
Model:
NDC 0409-2267-25
D-0576-2018
Lot Numbers:
74230DD (Exp 1FEB2019)
Date Ranges: 1FEB2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79238
Status: Resolved
Manufacturer: Hospira Inc. A Pfizer Company
Sold By: Hospitals; Pharmacies
Manufactured In: United States
Units Affected: a) 137,975 vials; b) 40,143 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.