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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Epinephrine Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: April 14, 2026
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Summary

International Medication Systems Ltd. is recalling 81,520 units of Epinephrine Injection, USP (1 mg/10mL). This medication, often used in emergency situations, is being recalled because of a lack of assurance of sterility, which means the product may not be sterile. The recall affects one specific lot distributed to hospitals and pharmacies nationwide.

Risk

Using a non-sterile injectable medication can lead to serious, life-threatening infections or systemic illness, as the drug is delivered directly into the patient's bloodstream or tissue. No injuries or incidents have been reported to date.

What You Should Do

  1. Identify if you have the affected product by checking for Epinephrine Injection, USP, 1 mg/10mL (0.1 mg/mL) in a 10mL vial with NDC 76329-3318-1.
  2. Check the packaging for lot number EA038A5 with an expiration date of 08/2026.
  3. Stop using the recalled product immediately. Contact the manufacturer or your distributor to arrange for the return of any remaining units.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report a concern.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL)
Variants: Rx only, 1 mg/10mL (0.1 mg/mL)
Lot Numbers:
EA038A5 (Exp 08/2026)
NDC:
76329-3318-1

Manufactured by International Medication Systems, Limited, an Amphastar Pharmaceutical Company.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98690
Status: Active
Manufacturer: International Medication Systems Ltd.
Sold By: hospitals; pharmacies
Manufactured In: United States
Units Affected: 81,520 units
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.