Sanis Carvedilol 25 mg Tablets Recalled Over Impurity 2026: Health Canada

Health Canada has posted a Type II health product recall for Sanis brand Carvedilol 25 mg tablets after the impurity N-nitroso-carvedilol was found to be possibly out of specification in a number of production lots. The notice, filed under recall number RA-82722, was published on October 5, 2026. It covers 13 lots distributed across Canada.

If you or someone you care for takes carvedilol, now is a good time to look at the label on your pharmacy bottle or box. Here is what the notice says and what you should do next.

Recalled Products at a Glance

The recall involves a single product from one brand. The details published by Health Canada are:

• Brand: Sanis
• Product: Carvedilol
• Dosage form and strength: Tablet, 25 mg
• Market authorization: DIN 02364956
• Company: Sanis Health Inc., 243 Consumers Rd, Toronto, ON M2J 4W8
• Recall class: Type II
• Identification number: RA-82722

Thirteen lot numbers are named in the recall: 665960, 663437, 663220, 663219, 661962, 659717, 658262, 656544, 653567, 653568, 652634, 652635 and 650922. Only tablets from these lots are affected.

What Triggered the Recall

The issue is listed as a product quality problem. According to the notice, the impurity N-nitroso-carvedilol may be out of specification in the affected lots. In other words, the level of this impurity may be above the limit the product is required to meet.

The notice does not describe how the problem was found. It also does not report any illnesses, injuries or adverse reactions linked to the affected tablets, and it does not give a timeline for when the lots were made or sold.

Areas and Consumers Impacted

Distribution of the affected lots is national, so the recall is not limited to one province or region. Health Canada lists the depth of the recall as retailers. That means the affected product was shipped to the retail level, which includes pharmacies and similar outlets, and is not limited to wholesalers.

Anyone who has been dispensed Sanis Carvedilol 25 mg tablets could be affected. Because patients often receive their medication in pharmacy-labelled containers, the lot number may not be obvious at first glance. Checking the packaging or asking your pharmacist is the surest way to find out.

Steps Consumers Should Take

Health Canada gives a short list of actions for people who use this medication:

• Verify whether your product is affected by checking the brand, strength, DIN and lot number against the list above.
• Consult your healthcare provider before discontinuing use of the affected product, or if you have any health concerns.
• Contact the recalling firm, Sanis Health Inc., if you have questions about the recall.
• Report any health product side effects to Health Canada through its adverse reaction reporting process.
• Report any other health product safety complaints to Health Canada.

The most important point is the second one. Carvedilol is a prescription medication, and the notice asks people to talk to a healthcare provider before they stop taking it. Do not change or stop your treatment on your own. Call your doctor or pharmacist first, and they can advise you on the best course of action for your situation.

What Type II Means

Health Canada classifies this as a Type II recall. The notice itself does not spell out what that class means, so consumers who want to know more should consult Health Canada directly. The classification is shown alongside the recall number and the national distribution on the official notice.

From the Agency

Health Canada published the alert as a health product recall under its drugs and health products program. Its summary states that the impurity, N-nitroso-carvedilol, may be out of specification in the affected lots. The agency’s advice is that people consult a healthcare provider before stopping use of the product, and that anyone with questions contact the recalling firm.

The notice was issued for the general public, healthcare professionals and industry. Patients, pharmacists and prescribers are all encouraged to review it. People who want to be told about future recalls and safety alerts can subscribe to Health Canada’s email notifications through the recalls and safety alerts website.

Bottom Line

This recall covers 13 specific lots of Sanis Carvedilol 25 mg tablets sold across Canada. If you take this medication, match your lot number against the list, speak with your doctor or pharmacist before making any change to your treatment, and report any side effects to Health Canada. The full official notice, RA-82722, is available on the Government of Canada recalls and safety alerts website.