Epinephrine Injection Recall: Sterility Concerns

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified May 1, 2026.

Urgent Recall: Epinephrine Injection Due to Sterility Concerns

Earlier this week, International Medication Systems Ltd., an Amphastar Pharmaceutical Company, confirmed a voluntary product recall in the United States. This impacts their EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only. As a parent, homeowner, or just someone who cares about safety, you need to know if you or someone you love could be affected.

Specifically, International Medication Systems is recalling lot number EA038A5, with an expiration date of August 2026. Based on the official recall notice, the reason for this action is a "Lack of Assurance of Sterility." That's a serious concern for any injectable medication. Don't take this lightly.

What's the Risk to Your Family?

A lack of sterility assurance means there's a chance the injection could be contaminated. If that happens, using it could lead to serious infection. Nobody wants to find out their life-saving medication is actually dangerous.

• The recalled product is EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL).
• It's packaged as "Rx only" and distributed by International Medication Systems, LIMITED, So. El Monte, CA 91733.
• The specific lot number to watch out for is EA038A5, expiring in 08/2026.
• The NDC number is 76329-3318-1.

According to the FDA, this is classified as a Class II recall. That means using the affected product could cause temporary or medically reversible adverse health consequences. While the risk of serious issues is lower than a Class I recall, this isn’t something you can ignore. The company distributed 81,520 units across the U.S., so many American shoppers could have this product at home.

What To Do If You Have the Recalled Epinephrine

Discovering you have a recalled medication can feel overwhelming. It's important to act quickly to protect yourself and your family.

1. Immediately stop using the EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL) with lot number EA038A5, and separate it from other medications to prevent accidental use.
2. Contact your healthcare provider or pharmacist to discuss alternative epinephrine options and ensure you have a safe replacement readily available. Tell them about the recall and ask for guidance.
3. Carefully inspect your epinephrine injection kit; if you find the recalled lot number EA038A5 printed on the vial or packaging, do not administer the injection under any circumstances.
4. Report any adverse reactions or quality problems experienced after using the recalled product to the FDA's MedWatch Adverse Event Reporting program, either online or by downloading and submitting the form.

Who is International Medication Systems?

International Medication Systems Ltd. is a pharmaceutical company focusing on injectable medications. They are an Amphastar Pharmaceutical Company. The company is based in So. El Monte, California.

While this recall is concerning, it's important to remember that pharmaceutical companies sometimes issue recalls to ensure product safety. It doesn't necessarily mean the company always has problems. However, staying informed is essential for U.S. consumers. The agency confirmed that this recall affects products sold across the U.S.

The FDA routinely monitors the pharmaceutical industry and issues recall notices when necessary. In fact, the FDA has issued dozens of recalls already this year, so this action is part of their normal oversight. This particular recall affects a prescription medication distributed nationwide.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.

Frequently Asked Questions

Q: Which specific product is being recalled?

It's the EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, from International Medication Systems, LIMITED, with lot number EA038A5 and an expiration date of 08/2026.

Q: Why is the epinephrine being recalled?

The recall is happening because there's a "Lack of Assurance of Sterility," meaning the product might not be sterile and could cause infections.

Q: How do I find the lot number on my epinephrine injection?

Check the label on the vial and the outer packaging of the EPINEPHRINE Injection; the lot number (EA038A5 in this case) and expiration date (08/2026) are usually printed clearly on both.

Q: What should I tell my doctor if I used the recalled epinephrine?

Inform your doctor that you used the recalled EPINEPHRINE Injection, USP with lot number EA038A5, mention the date of use, and describe any unusual symptoms or reactions you experienced after the injection.

Q: Can I get a refund or replacement for the recalled epinephrine?

Yes, contact your healthcare provider or pharmacist immediately to get a safe replacement and discuss return options for the recalled product. They will guide you on how to proceed.