Health Canada has posted recalls for carvedilol 25 mg tablets made by three companies, saying an impurity called N-nitroso-carvedilol may be out of specification in certain lots.
The three notices were published on Oct. 5, 2026, and two were updated on Oct. 6. They cover products sold under the Pro Doc, Sanis and PMS-Carvedilol names. Health Canada classified each recall as Type II and said the products were distributed nationally, at the retailer level.
Carvedilol is a prescription medication. People who take it should not stop on their own, according to the guidance in all three notices. Health Canada said anyone with health concerns should talk to a health care provider before stopping the affected product.
A Type II classification is one of Health Canada’s recall levels. It is generally used when the use of a product may cause temporary health problems or when the chance of serious effects is considered remote. The notices do not report any illnesses linked to the lots.
The notices say the impurity “may be out of specification in the affected lots.” They do not give a measured level of the impurity, and they do not say how long people may have been taking the affected tablets.
Here are the products and lots named in each notice. Check the label on your pill bottle or ask your pharmacist to confirm.
Pro Doc Carvedilol 25 mg tablets (recalling firm: Pro Doc Ltée, Laval, Que.; DIN 02324539; recall number RA-82726). Lots:
- 650921
- 651648
- 654750
- 656546
- 658261
- 659716
- 661963
- 663440
- 665341
- 667133
Sanis Carvedilol 25 mg tablets (recalling firm: Sanis Health Inc., Toronto; DIN 02364956; recall number RA-82722). Lots:
- 650922
- 652634
- 652635
- 653567
- 653568
- 656544
- 658262
- 659717
- 661962
- 663219
- 663220
- 663437
- 665960
PMS-Carvedilol 25 mg tablets (recalling firm: Pharmascience Inc., Montreal; DIN 02245917; recall number RA-82725). Lots:
- 650920
- 650923
- 650924
- 650927
- 651646
- 651647
- 653566
- 653569
- 654749
- 657006
- 657007
- 658263
- 659714
- 659715
- 661964
- 661965
- 663218
- 663438
- 663439
- 665961
The lot number is normally printed on the label or the side of the bottle or box. Pharmacies also keep records of what they dispensed, so a pharmacist can usually look up the lot on a recent fill. The notices did not list expiry dates.
Health Canada’s advice in each notice follows the same steps. Check whether your product is one of the affected lots. Talk to a health care provider before stopping the medication, or if you have any health concerns. Contact the recalling company with questions. Report any side effects to Health Canada.
Each notice also asks people to report other product safety complaints to Health Canada. Reports on side effects and complaints can be filed through the department’s website, and the recall pages link to the reporting forms.
Recalls like this one are a routine part of how Health Canada monitors drug quality. Nitrosamine-type impurities have prompted recalls of several medications in recent years, and regulators set limits on how much of them a product can contain. The agency’s recall database is updated as new notices are posted, so the lots and companies named here could change.
Anyone who is unsure whether their tablets come from one of these companies can read the pharmacy label, which lists the manufacturer or brand name, or ask the pharmacy. Pharmacists can also tell patients whether a replacement from a different manufacturer is available, and what to do in the meantime, since carvedilol is a medication many people take every day.
This article is based on official guidance from Health Canada and is provided for general public information. It’s not a substitute for medical advice, if you have questions about how this applies to you, talk to your doctor or pharmacist.
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Sources: Health Canada recall notices for Pro Doc Carvedilol 25 mg tablets, Sanis Carvedilol 25 mg tablets and PMS-Carvedilol 25 mg tablets, via the Recalls and Safety Alerts database.
