Health Canada Authorizes South Korean BONKY Calcitriol Injection Import 2026

Health Canada has authorized the exceptional, temporary importation of a South Korean drug product to help resolve a critical shortage of a medication used in dialysis and kidney disease care. The regulator issued a health professional risk communication on August 24, 2026, permitting the sale of South Korean-authorized BONKY Injection, 1 mcg/mL Calcitriol, even though its carton and ampoule labels are printed only in Korean.

The move comes as Canadian-authorized Calcitriol Injection USP, 1 mcg/mL, made by SteriMax Inc., remains in short supply nationwide. Because the drug is considered medically necessary, Health Canada added the South Korean product to its List of Drugs for Exceptional Importation and Sale rather than leave hospitals and dialysis clinics without an alternative.

Products Affected by This Recall

The product involved is BONKY Injection, 1 mcg/mL Calcitriol, marketed by YuYu Pharma Inc. and manufactured by Aju Pharm Co., Ltd. in Pyeongtaek, South Korea. It is authorized in the Republic of Korea under identifying code 199801831 and is being brought into Canada by importer Septa Pharmaceuticals Inc. of Mississauga, Ontario.

• Same active ingredient (calcitriol), strength (1 mcg/mL), dosage form and intravenous route as the Canadian product
• Different brand name, carton design and ampoule label than the Canadian-authorized version
• Sold in packs of 10 x 1 mL ampoules instead of the Canadian 25 x 1 mL ampoule pack
• No Canadian Drug Identification Number (DIN) and no barcode compatible with Canadian medication scanning systems

Why Was This Recall Issued?

This is not a product-safety recall in the traditional sense. Rather, it is a supply-shortage alert meant to flag important differences healthcare workers must watch for when dispensing a substitute drug. Health Canada says the South Korean carton lists the strength as 1 µg, while the ampoule itself reads 1 mcg/mL — the same measurement written two different ways. Staff are told to always check the ampoule, not the carton, when verifying dosage.

More seriously, the South Korean labeling includes a specific warning that glass fragments can enter the solution when the ampoule is snapped open, potentially causing adverse effects if not handled carefully. This warning does not appear on the Canadian-authorized product and is unique to the imported version.

Who Is Affected?

The alert is directed at healthcare professionals, not the general public. It applies specifically to hospitals and treatment settings such as dialysis clinics and renal units across Canada that may receive or already stock the South Korean-labeled product while the domestic shortage continues. Calcitriol Injection USP is used to manage hypocalcemia in patients on chronic renal dialysis and to help lower elevated parathyroid hormone levels linked to renal osteodystrophy. It is not recommended for pediatric patients, a caution that applies equally to the imported version even though it is not printed on the foreign-language label.

What Should You Do?

Health Canada is asking pharmacies and hospitals to generate their own stickers or auxiliary labels for the outer carton, and ampoules where feasible, clearly marking the active ingredient and strength in mcg/mL so staff can identify the product correctly and avoid dispensing errors. Facilities may also need a facility-generated sticker to enable barcode scanning, since the imported ampoules will not scan automatically in Canadian systems.

Clinicians are advised to keep consulting the existing Canadian Product Monograph for Calcitriol Injection USP by SteriMax Inc. for guidance on indications, contraindications, warnings, dosing and storage, even while using the substitute stock. Any serious or unexpected side effects observed in patients receiving BONKY Injection should be reported both to Septa Pharmaceuticals Inc. and to Health Canada.

Official Statement

Health Canada said it worked directly with Septa Pharmaceuticals Inc. to prepare the communication and is distributing it through the Recalls and Safety Alerts Database and the MedEffect e-Notice system. The alert is signed by Devinder Kumar, President and CEO of Septa Pharmaceuticals Inc., whose company can be reached for label-correction requests or adverse-event reports.

Consumers and healthcare providers with questions can contact Health Canada’s Regulatory Operations and Enforcement Branch, or report suspected adverse reactions toll-free through MedEffect Canada.