Femyso has been recalled across Canada after one lot of the medication may contain two cartons of mifepristone or two cartons of misoprostol instead of the intended combination of one carton of each.
Health Canada published the recall on October 21, 2026, identifying the affected product as Femyso mifepristone 200 mg and misoprostol 200 mcg tablets.
The recall applies nationally and has been classified as a Type II health product recall.
Table of Contents
Which Femyso product is affected?
The recall affects Lupin Pharma Canada Ltd.’s Femyso kit with Drug Identification Number 02560569.
Health Canada listed the affected lot as NR02557A-R.
Consumers should compare the lot number on their packaging with the recall notice before using the product.
| Product | Details |
|---|---|
| Brand | Femyso |
| Medicines | Mifepristone 200 mg and misoprostol 200 mcg |
| Dosage form | Kit containing tablets |
| Affected lot | NR02557A-R |
| Distribution | Canada-wide |
| Recall depth | Retailers |
| Recall classification | Type II |
Why Femyso was recalled
The affected lot may have been packaged incorrectly.
Some kits could contain two green mifepristone cartons or two pink misoprostol cartons, rather than one carton of each medication.
That means the issue concerns the contents and packaging arrangement of the kit, not a newly identified contamination problem with the medicines themselves.
However, receiving duplicate cartons could leave a patient without the intended medication combination.
Femyso contains mifepristone and misoprostol.
Health Canada’s product information lists the two active ingredients as mifepristone 200 mg and misoprostol 200 mcg.
What patients should do
Health Canada advises consumers to first verify whether their product matches the recalled lot.
- Check the product name and lot number on the package.
- Do not make medication changes without speaking with a healthcare provider.
- Contact a doctor, pharmacist or other healthcare provider if the affected product has been used or if the kit does not contain the expected combination.
- Contact Lupin Pharma Canada with questions about the recall.
- Report suspected side effects or other safety complaints to Health Canada.
The federal notice specifically advises patients to consult a healthcare provider before discontinuing use of the affected product or if they have health concerns.
What the recall means for pharmacies and retailers
The recall’s listed depth is retailers, meaning the company’s recall action is directed through the retail distribution level.
Pharmacies and other retailers that received the affected lot are expected to identify and remove the impacted kits from sale.
Patients who received Femyso through a pharmacy should contact that pharmacy for product-specific instructions.
They should keep the packaging available because the lot number and other identifying details may be needed to confirm whether the kit is affected.
What is a Type II recall?
A Type II recall is used for a situation in which use of, or exposure to, a product may cause temporary adverse health consequences or where the likelihood of serious harm is considered remote.
The classification does not mean every package is defective, and the recall applies only to the identified product and lot.
Consumers should therefore avoid assuming that all Femyso kits are affected.
The key identifier in this notice is lot NR02557A-R.
What happens next
Lupin Pharma Canada and retailers will continue the recall process, while Health Canada will monitor follow-up actions.
Patients who are unsure whether they received the affected lot should seek confirmation from their pharmacy or healthcare provider rather than relying on the colour of the carton alone.
The recall notice was issued by Health Canada on October 21, 2026, and remains the authoritative source for the affected lot and consumer instructions.
Frequently Asked Questions
What Femyso product has been recalled?
One lot of Femyso mifepristone 200 mg and misoprostol 200 mcg tablets has been recalled across Canada.
What is the recalled Femyso lot number?
The affected lot is NR02557A-R.
Why was Femyso recalled?
Some kits may contain two green mifepristone cartons or two pink misoprostol cartons instead of one carton of each medication.
Should patients stop taking recalled Femyso?
Patients should consult a healthcare provider before discontinuing use and should seek advice if they have used the affected product or have health concerns.
Where was the recalled Femyso distributed?
Health Canada says the affected product was distributed nationally, with the recall directed at the retail level.
Fact-Checked: Key product, lot, distribution, classification and consumer-action details were checked against Health Canada’s official recall notice and product information.
Disclaimer: This article is for general information only and does not replace advice from a pharmacist, physician or other qualified healthcare provider.