Nationwide EpiPen and EpiPen Jr. Recall: What Patients Need to Know

Clear instructions for identifying impacted lots and obtaining replacement auto-injectors.

By Sneha Tete, Integrated MA, Certified Relationship Coach

Created on Sep 22, 2025

Clear instructions for identifying impacted lots and obtaining replacement auto-injectors.

Nationwide EpiPen and EpiPen Jr. Recall: Crucial Updates for Allergy Patients

On Friday, the U.S. Food and Drug Administration (FDA) announced the recall of multiple lots of Mylan’s EpiPen and EpiPen Jr. These auto-injectors, used to treat life-threatening allergic reactions, may contain a defective part that could prevent activation during an emergency. The news has left many allergy patients and families on high alert, concerned about their safety and next steps. This comprehensive guide explains everything you need to know about the recall, including what devices are affected, why the recall was issued, what to do if you have a recalled device, and important contact resources.

What Is an EpiPen and Why Is It Vital?

EpiPen is a brand-name epinephrine auto-injector, a medical device that delivers a measured dose of epinephrine to treat severe allergic reactions (anaphylaxis). EpiPens are considered a critical, first-response medicine for anyone with serious allergies to foods, insect stings, medications, or other allergens. If a person experiences anaphylaxis, timely injection of epinephrine can be the difference between life and death.

In addition to EpiPen recalls, concerns about other medications are also prevalent. Stay informed by exploring the latest updates on medication safety. You can learn about the GlaxoSmithKline asthma inhaler recall that impacts numerous patients, shedding light on potential risks and necessary precautions.

EpiPen (0.3 mg): Designed for adults and children weighing more than 66 lbs (30 kg).
EpiPen Jr. (0.15 mg): For children weighing 33-66 lbs (15-30 kg).
Manufactured by: Meridian Medical Technologies, distributed by Mylan.

Because EpiPens are often used in emergency, time-sensitive situations, device reliability is of utmost importance.

Details of the 2017 EpiPen Recall

Which Devices Are Affected?

The recall applies specifically to:

EpiPen auto-injectors, 0.3 mg strength
EpiPen Jr. auto-injectors, 0.15 mg strength

The recall does not include generic versions. Only certain product lots distributed in the United States between December 2015 and July 2016 are affected.

Why Are These EpiPens Being Recalled?

The products are being recalled due to the potential for a defective part inside the auto-injector which could lead the device to fail to activate during use. This means the EpiPen might not deliver the lifesaving dose of epinephrine when needed, increasing the risk of a potentially life-threatening allergic reaction going untreated.

If you're concerned about medication recalls, ensure you are aware of other significant advisories, such as the Children’s Advil recall due to packaging issues that could affect dosing. Keeping informed about such recalls can be essential for safeguarding your family’s health.

While the number of confirmed failures is reportedly small, the implication of a failed epinephrine shot in an emergency is severe, and has led to preemptive, nationwide action.

Summary of Core Facts

Device	Strength	Manufactured By	Distributed By	Distribution Period	Generic Included?
EpiPen	0.3 mg	Meridian Medical Technologies	Mylan	Dec 2015 – Jul 2016	No
EpiPen Jr.	0.15 mg	Meridian Medical Technologies	Mylan	Dec 2015 – Jul 2016	No

What Are the Risks?

In the event of anaphylaxis, failure to administer epinephrine quickly can cause:

Breathing difficulties
Swelling of the throat or tongue
Dizziness or fainting
Cardiac arrest

According to the FDA, even though there have been only a few reported cases of device failure, any use of a defective EpiPen can be life-threatening if the medication is not delivered as expected.

In light of ongoing recalls, it’s crucial to be aware of all products that may be affected. For example, our detailed guide on Eye Drops Recalls 2023–2024 provides a full list and safety information, ensuring you have the knowledge to protect yourself and your loved ones.

Why Now? Understanding the Timeline

Reports of EpiPen malfunctions have increased since the 2009 device redesign after Mylan acquired the rights to EpiPen. Lawsuits and FDA records reveal that in the two years following the redesign, more than 300 adverse event reports were filed, compared to 256 in the entire 16 years prior. This latest recall is specifically due to device activation concerns for certain lots.

Is the Generic EpiPen or Other Brands Affected?

No, the recall does not apply to the generic EpiPen auto-injector. Mylan’s generic version, introduced in late 2016, is manufactured differently. Check your labeling to determine if your auto-injector is a brand-name EpiPen, EpiPen Jr., or the generic equivalent.

How to Identify a Recalled EpiPen or EpiPen Jr.

If you use or store an EpiPen, check to see if your device belongs to one of the 13 affected lots. This information is available via Mylan’s website or by contacting the recall support number.

To check your EpiPen:

Find the lot number and expiration date printed on the device’s label or box.
Compare this information to the official Mylan recall list.
If your product matches, contact the helpline for next steps (see below).

What Should You Do If You Have a Recalled EpiPen?

The FDA and Mylan both strongly advise you NOT to dispose of your EpiPen until you have a replacement. Even a potentially defective auto-injector may still work in an emergency and should not be discarded until a new device is available.

In addition to EpiPen information, it's wise to be informed about other recalls. Our comprehensive Bayer’s Alka-Seltzer Plus Recall consumer guide offers critical insights that could help you make informed decisions about your health and safety.

Steps for Impacted Patients

Continue to carry your current EpiPen or EpiPen Jr.
Check your device’s lot number against the official recall list.
Contact Stericycle at 877-650-3494 to return recalled devices and obtain a voucher for a replacement auto-injector.
Visit your pharmacy to redeem your voucher and collect your new device.
For further questions, contact Mylan Customer Relations at 800-796-9526 or email customer.service@mylan.com.

If you use your EpiPen for a severe allergic reaction, even if it fails or appears to malfunction, seek emergency medical help immediately.

Frequently Asked Questions (FAQs)

Q: Why were some EpiPens recalled?

A: The recall was issued because some devices may contain a faulty part that could prevent the injector from activating and delivering lifesaving epinephrine in an emergency.

To further safeguard your family, consider learning about the Nationwide Recall of Children’s Cough Syrup. Staying updated on such information is vital to ensuring you have safe and effective medications on hand for your children.

Q: Which versions of EpiPen are affected?

A: Only certain lots of EpiPen (0.3 mg) and EpiPen Jr. (0.15 mg), distributed in the U.S. between December 2015 and July 2016, are affected. The generic version is not included.

Q: What should I do if my EpiPen is part of the recall?

A: Continue carrying your device until you receive a replacement. Call Stericycle (877-650-3494) to arrange for replacement and return. Do not discard your EpiPen unless you have a new one in hand.

Q: Can my pharmacy replace my recalled EpiPen?

A: Pharmacies will provide a replacement once you have confirmation or a voucher from the recall program, but availability may vary depending on supply. Contact Stericycle for instructions before visiting your pharmacy.

Q: How serious is the risk?

A: While only a few device failures have been reported, the consequences of a malfunction during an anaphylactic reaction can be severe or fatal. This risk is why the FDA and Mylan issued the recall as a precautionary measure.

Background: FDA and Manufacturer’s Response

Both the FDA and Mylan have responded quickly to consumer concerns. In their announcements, they emphasized that:

Prompt action is being taken out of “an abundance of caution.”
Patients are advised to hold onto their current EpiPen until a replacement becomes available.
Further updates and additional information are available on Mylan’s recall website and via the FDA’s official alerts.

Testing on the recalled devices did not uncover the fault in every impacted unit, but even rare failures warrant action given the device’s critical purpose.

Legal and Regulatory Aftermath

The EpiPen recall has led to increased scrutiny of both Mylan and Meridian Medical Technologies. After prior reports of device failure, the FDA cited Meridian for not thoroughly investigating hundreds of complaints. Lawsuits were filed claiming device failures during emergencies, with some accusations stating that EpiPens were not reliably deploying medication as needed.

Key companies involved:

Mylan N.V. (distributor and marketer)
Meridian Medical Technologies (manufacturer, subsidiary of Pfizer)
Pfizer Inc. (parent company of Meridian)

In 2017, the FDA issued a warning letter to Meridian Medical Technologies for “significant violations” of regulations, citing failure to formally investigate hundreds of malfunction reports.

Resources for Concerned Patients

Stericycle Recall Hotline: 877-650-3494 (for replacement and returns)
Mylan Customer Relations: 800-796-9526
Mylan Email: customer.service@mylan.com
FDA Recall Pages and Alerts (for updates and new lots, check FDA.gov)
Mylan’s official recall information: Available on their website

Safety Reminders for Auto-Injector Users

Always check the lot number and expiration date of medicines and medical devices upon receipt.
Do not use expired or compromised devices. Replace before expiration when possible.
Read and follow all device instructions and consult pharmacists if you have any concerns.
After using an EpiPen, seek immediate emergency medical attention—even if symptoms improve.

Conclusion: Stay Informed and Protected

The nationwide recall of EpiPen and EpiPen Jr. reflects both the gravity of medical device safety and the responsive action of regulatory agencies. If you or a loved one uses these devices, take the necessary steps to verify your device, contact the recall program, and ensure you always carry a reliable epinephrine auto-injector. Ongoing vigilance and accurate information can make all the difference in an emergency.

Nationwide EpiPen and EpiPen Jr. Recall: What Patients Need to Know

Nationwide EpiPen and EpiPen Jr. Recall: Crucial Updates for Allergy Patients

What Is an EpiPen and Why Is It Vital?