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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

Henry Schein and Glove Club Adrenalin Injection Recalled for Incorrect Expiration

Agency Publication Date: February 21, 2024
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Summary

Henry Schein Inc. and Glove Club HSI Gloves Inc. have recalled 1,099 vials of Adrenalin (epinephrine) Injection 1mg/mL (1mL single dose vial). The recall was initiated because the repackaged pouch labels list an incorrect expiration date. Using epinephrine that has lost its potency past its true expiration date can be dangerous during a life-threatening allergic reaction. No injuries or incidents have been reported to date.

Risk

The incorrect expiration date on the label could lead healthcare providers to use the medication after it has lost its potency, potentially resulting in treatment failure during an emergency. This is a critical risk for a drug used to treat anaphylaxis and other life-threatening conditions.

What You Should Do

  1. This recall affects Adrenalin (epinephrine) Injection 1mg/mL (1mL single dose vials) with Repack NDC 0404-9810-01 and Original NDC 42023-159-25. Affected products are marked with Repackaged Lot # 39747 (incorrectly listed as Exp 01/26) and Original Lot # 64103 (Exp 11/24).
  2. Stop using the recalled product immediately.
  3. Contact Henry Schein Inc., Glove Club HSI Gloves Inc., or your medical supplier to arrange for the return of the affected medication.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer return coordination.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Adrenalin (epinephrine) Injection 1mg/mL (1mL single dose vial)
Variants: 1mg/mL, 1mL single dose vial, Rx only
Lot Numbers:
64103 (Exp 11/24)
39747 (Exp 01/26)
NDC:
42023-159-25
0404-9810-01

Original NDC 42023-159-25; Repack NDC 0404-9810-01. The expiration date listed on the Repack Pouch Label is incorrect.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93839
Status: Resolved
Manufacturer: Henry Schein Inc. and Glove Club HSI Gloves Inc.
Sold By: Henry Schein Inc.; Glove Club HSI Gloves Inc.
Manufactured In: United States
Units Affected: 1,099 Single Dose 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.