Lupin Femyso Tablet Kits Recalled Over Carton Packaging Error: Health Canada

Health Canada has posted a Type II health product recall for a single lot of Femyso, a Mifepristone 200 mg and Misoprostol 200 mcg tablet kit distributed in Canada by Lupin Pharma Canada Ltd. The notice was published on October 21, 2026 under identification number RA-82831 and points to a packaging problem rather than a change in the medication itself.

According to the notice, the affected lot may contain two green Mifepristone cartons or two pink Misoprostol cartons instead of one of each. The product is distributed nationally, and the depth of the recall is listed as retailers.

Recalled Products at a Glance

• Product: Femyso Mifepristone 200 mg / Misoprostol 200 mcg tablet (kit, tablet)
• Brand and company: Lupin Pharma Canada Ltd.
• DIN: 02560569
• Affected lot number: NR02557A-R
• Recall class: Type II
• Recall number: RA-82831
• Distribution: National (Canada)
• Issue category: Health products – Packaging

Only one lot is named in the notice. If your Femyso kit carries a different lot number, it is not part of this recall based on the information Health Canada has published.

What Triggered the Recall

The issue is classified as a packaging problem. Each Femyso kit is meant to hold one green carton of Mifepristone and one pink carton of Misoprostol. In the affected lot, a kit may instead contain two green Mifepristone cartons, or two pink Misoprostol cartons.

That matters because the two medicines are packaged together as a combination product, and a kit with two identical cartons does not match the intended configuration. The Health Canada notice describes the carton mix-up but does not explain how it happened. It also does not say how many kits are affected, and it does not report any injuries or adverse reactions linked to the problem.

The notice is also listed with a previous alert carrying the same title, which suggests this posting follows an earlier notice on the same issue.

Who Should Be Concerned

Because the product has national distribution, the recall applies across Canada. Health Canada lists the audience for the notice as the general public, healthcare professionals and industry, so patients, prescribers, pharmacies and other retailers may all need to take note.

Anyone who has been prescribed or dispensed Femyso should check the lot number printed on their package. Healthcare providers and pharmacies that hold stock should do the same.

Steps Consumers Should Take

Health Canada has outlined the following actions in the notice:

• Verify whether your product is affected by checking the lot number against NR02557A-R.
• Consult your healthcare provider before discontinuing use of the affected product, or if you have any health concerns.
• Contact the recalling firm, Lupin Pharma Canada Ltd., if you have questions about the recall.
• Report any health product related side effects to Health Canada through its adverse reaction reporting process.
• Report any other health product safety complaints to Health Canada.

The key point for patients is the second step. The notice does not tell people to simply stop using the medication on their own. Instead it asks them to speak with a healthcare provider first, who can advise on whether a kit from the affected lot should be replaced and what to do next.

If you open your kit and find two cartons of the same color, keep the packaging and the lot number handy when you call your provider or pharmacy. That will help them confirm quickly whether your product belongs to the affected lot.

Regulatory Response

The recall was published by Health Canada and classified as Type II. The notice lists Lupin Pharma Canada Limited, located at 550-1111 rue St-Charles Ouest in Longueuil, Quebec, as the company involved. No telephone number, email address or refund process is given in the notice.

Health Canada says anyone with questions can contact the recalling firm, and it encourages consumers and professionals to report side effects or safety complaints so the department can monitor the situation. The original published date and the last updated date on the notice are both October 21, 2026.

Consumers who want to follow future alerts of this kind can subscribe to recall notifications on the Government of Canada recalls and safety alerts website, which publishes new and updated notices as they are issued.

Bottom Line

This 2026 Femyso recall is limited to lot NR02557A-R and centers on a carton packaging error. Check your lot number, talk to your healthcare provider before making any change to your treatment, and reach out to Lupin Pharma Canada Ltd. if you have questions.