FDA alert: What to do if your Omnipod may be under-delivering insulin

People who use certain Omnipod insulin pods should check their supplies now. On May 26, 2026, the FDA issued an Early Alert about specific lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System (Omnipod Eros) pods that may under-deliver insulin.

If you are wearing a pod from an affected lot, change it right away and switch to a pod that is not affected. If you do not have a replacement pod, contact your diabetes care team promptly about a backup insulin plan and ask Insulet about replacement instructions.

What FDA alerted people about on May 26, 2026

According to the FDA, some pods from specific lots may have a small tear in the cannula tubing just above the skin. If that happens, some insulin can leak outside the body instead of being delivered as intended.

That can lead to high blood sugar and, in more serious cases, diabetic ketoacidosis, or DKA. The FDA said this May 2026 alert is a new issue and separate from Insulet’s earlier March 2026 Omnipod 5 removal.

As of the FDA update, Insulet had reported 24 serious injuries and no deaths linked to this issue. The agency said it was still reviewing the problem as of the page update dated June 4, 2026.

Which Omnipod systems and lots are affected

The affected products named by the FDA are:

Omnipod 5 Automated Insulin Delivery System
Omnipod DASH Insulin Management System
Omnipod Insulin Management System, also called Omnipod Eros

Not every pod is affected. The issue is limited to specific lots. The FDA says users should check the lot number on the pod tray lid, the pod box, or the pod itself and compare it with the affected-lot information in the FDA and manufacturer notices.

If one pod in a box is from an affected lot, the FDA says not to use any pods from that box. All pods in a single box come from the same lot.

What insulin under-delivery can look like

This problem may be easy to miss. The FDA says some people may notice wetness on the skin, damp adhesive, or the smell of insulin near the pod site. But in some cases, leakage may not be obvious.

You may also notice that your glucose is rising or staying high even though insulin delivery appears to be happening. If you use Omnipod 5 in Automated Mode, you might see an Automated Delivery Restriction alert telling you to troubleshoot. But the FDA also warns that this issue may happen without any alert at all.

The alert does not mean your continuous glucose monitor is failing. The FDA says CGM systems and CGM readings are not affected by this specific device problem.

Immediate steps if your pod is affected or you are not sure

If you have Omnipod supplies at home, check them before your next pod change. If you are currently wearing a pod and discover it is from an affected lot, the FDA says to change it immediately so insulin delivery can resume with a pod that is not affected.

If you find unused affected pods, do not set them aside for future use. Follow the manufacturer’s replacement instructions. The FDA says affected customers should request replacements through Insulet and can contact Insulet Product Support at 1-800-641-2049, which the company says is available 24 hours a day.

If your pod supply may run short because of this correction, contact your diabetes clinician early. Ask what backup insulin plan you should use if you run out of safe pods. Do not wait until your last usable pod is gone. Coverage, refill timing, and replacement logistics can vary.

When high glucose becomes a ketone or DKA emergency

Pump problems and missed insulin are well-known triggers for DKA because many pump users rely on rapid-acting insulin throughout the day. The CDC says people with diabetes should check ketones when they are sick or if their blood sugar is 250 mg/dL or higher.

MedlinePlus also says DKA can become a medical emergency and that warning signs can include vomiting, trouble breathing, fruity-smelling breath, confusion, severe thirst, and dehydration. If your glucose stays very high, your ketones are positive, or you have several of those symptoms at once, seek urgent medical care right away.

If you have trouble breathing, cannot keep fluids down, become confused, or feel seriously ill, do not wait for a routine callback. Go to urgent care or the emergency room, or call 911 if the symptoms are severe.

What to keep on hand now

This FDA alert is a good reminder to keep a small backup kit ready, especially if you use pump-delivered insulin. The American Diabetes Association recommends having key diabetes supplies available before you need them.

Your current pod lot information and recall or alert notice
A backup insulin plan from your clinician
Ketone test strips
A glucose meter and supplies
Extra pump or CGM supplies
Your prescriber’s contact information
After-hours numbers for your clinic, pharmacy, or diabetes educator

If you care for a child, older adult, or someone who may not notice rising glucose symptoms quickly, review that plan together now. Caregivers should know where ketone strips are, how to reach the diabetes team, and what symptoms mean it is time for urgent or emergency care.

What is known, and what is still uncertain

What is known is that the FDA has identified a potentially high-risk problem affecting specific lots of Omnipod 5, DASH, and Eros pods, and that the issue can lead to insulin under-delivery and DKA. What is also clear is that some leaking pods may not trigger an obvious warning.

What is not yet clear is whether the FDA will add more affected lots or take further action as the review continues. That is why it is important to keep checking the official notice if you use these systems.

For most readers, the next reasonable step is to check your pod lot numbers today, make sure you have ketone supplies, and confirm your backup insulin instructions with your diabetes care team if your safe pod supply looks thin.

Sources

Editorial note: Weence articles are researched from cited public-health, medical, regulatory, journal, and reputable news sources and may be drafted with AI assistance. They are checked for source support, clarity, and safety guardrails before publication.

This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.