Nine Sarclisa Vials Recalled in Nova Scotia Over Freezing Risk 2026

Health Canada has recalled a small number of Sarclisa injection vials from three locations in Nova Scotia after learning that some units of a single lot may have been frozen during shipment. The recall, issued on September 23, 2026, affects just nine vials out of the total lot, but the agency has classified the action as Type I, its most serious recall category, reserved for situations where using the affected product could reasonably cause serious health consequences.

Sarclisa, manufactured by Sanofi-Aventis Canada Inc., is a biologic cancer medication administered by intravenous infusion in clinical settings, typically as part of treatment regimens for multiple myeloma. Because it is a biologic product, its stability depends heavily on being stored and transported within a specific temperature range, which is why any deviation such as freezing can raise concerns about whether the medication still performs as intended.

Recalled Products at a Glance

The recall applies to a single product configuration sold under the Sarclisa brand name. Below are the key identifying details for the affected lot:

• Brand: Sarclisa
• Market Authorization: DIN 02498243
• Dosage Form: Single-use vial
• Strength: 500 mg/25 mL
• Lot Number: 5F028A

Health Canada has been explicit that consumers and healthcare providers should not assume their product is affected simply because the lot number matches. Only nine specific units, pulled from three Nova Scotia locations, are subject to this recall.

What Triggered the Recall

According to the notice, units from the affected lot may have been exposed to freezing temperatures while in transit. Freezing can alter the molecular structure of biologic drugs like monoclonal antibodies, potentially reducing their effectiveness or, in some cases, introducing safety risks. Health Canada listed the issue category as ‘Health products – Product quality,’ reflecting concerns about whether the medication met its intended specifications after the temperature exposure.

The narrow scope of the recall — just nine vials — suggests the issue was identified and contained quickly, likely through cold-chain monitoring during distribution rather than through reports of patient harm.

Where Were These Products Sold?

Distribution of the affected units was limited to Nova Scotia. Health Canada’s notice does not name the specific pharmacies, hospitals or clinics involved, but confirms the nine units were located across three sites within the province. Sarclisa is not sold directly to consumers over the counter; it is administered by healthcare professionals in hospital or clinic settings where infusion reactions can be managed if they occur.

What Consumers Need to Do Now

Because Sarclisa is a prescription infusion product handled entirely by medical staff, patients themselves are not expected to identify or return affected vials. Health Canada’s guidance is directed primarily at healthcare providers and institutions holding the product. Recommended steps include:

• Consult your healthcare provider for any health concerns related to a recent Sarclisa infusion.
• Do not assume a unit is affected solely because it carries lot number 5F028A — only nine specific vials from three Nova Scotia sites are involved.
• Contact the recalling firm, Sanofi-Aventis Canada Inc., with any questions about the recall.
• Report any suspected side effects linked to Sarclisa through Health Canada’s MedEffect adverse reaction reporting system.
• Report other product safety concerns through Health Canada’s Health Product Complaint Form.

From the Agency

Health Canada published the alert under its health product recall program, identifying the action with reference number RA-82683. The recall is formally classified as a Type I health product recall, the designation used when there is a reasonable probability that continued use of a product could cause serious adverse health consequences or death. The company involved, Sanofi-Aventis Canada Inc., is headquartered at 1755 Steeles Ave. West, Toronto, and is listed as the responsible party coordinating the recall response with Health Canada.

Health Canada has not indicated any confirmed reports of patient harm connected to the frozen units at the time of publication. The notice remains open for updates, and the agency has encouraged the public and healthcare professionals to subscribe to its alert system for future developments on this and other health product recalls.