Health Canada has issued an urgent recall for Blood Pressure Medication due to Contamination of Pink Candesartan Stains specific lots of Taro-Gliclazide MR (modified-release) tablets, a medication used to manage type 2 diabetes, due to potential contamination with candesartan, a blood pressure medication. The recall was prompted by the discovery of pink-colored stains on some tablets, identified as candesartan, which could pose serious health risks if consumed by patients not prescribed this drug.
The affected product, manufactured by Taro Pharmaceuticals Inc., is Taro-Gliclazide MR, available in 30 mg and 60 mg strengths. The contamination is believed to have occurred during the manufacturing process, leading to the unintended presence of candesartan, a medication used to treat hypertension and heart failure. For patients with diabetes who rely on gliclazide to control blood sugar, taking candesartan unknowingly could cause dangerous side effects, including low blood pressure, dizziness, or kidney issues, particularly in those with specific medical conditions or on other medications.
Health Canada has classified this as a Type I recall, indicating a high risk of serious health consequences. The agency has confirmed that the contamination was identified during routine quality control testing, and no adverse health events have been reported in Canada as of May 20, 2025.
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What Consumers Should Do
Health Canada advises patients to immediately stop using the affected lots of Taro-Gliclazide MR and consult their pharmacist or healthcare provider to verify if their medication is part of the recall. Consumers should not abruptly discontinue their diabetes medication without medical guidance, as this could lead to uncontrolled blood sugar levels. Pharmacists can provide replacement medication or alternative treatment options.
To identify affected products, check the lot numbers and expiry dates listed on the Health Canada recall notice at recalls-rappels.canada.ca. Consumers can return the product to their pharmacy for safe disposal or contact Taro Pharmaceuticals Inc. at 1-800-268-1975 for further instructions. Any adverse reactions should be reported to Health Canada’s Canada Vigilance Program at 1-866-234-2345 or online via the agency’s website.
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Recall Background and Response
The recall follows a similar incident reported on April 26, 2025, involving JAMP-Montelukast 10 mg tablets contaminated with pink candesartan fragments, suggesting potential issues in shared manufacturing facilities. Taro Pharmaceuticals has halted distribution of the affected lots and is working with Health Canada to investigate the contamination’s source. The company has also committed to implementing stricter quality control measures to prevent future incidents.
Health Canada is collaborating with the Canada Border Services Agency to block imports of the affected product and ensure all contaminated units are removed from the market. The agency is also urging pharmacies and healthcare providers to inspect their inventory and notify patients who may have received the recalled medication.
Health Canada’s Ongoing Efforts
This recall is part of Health Canada’s rigorous oversight of health products to ensure safety and compliance with the Food and Drugs Act. The agency has issued multiple recalls in 2025 for contaminated medications, including those involving nitrosamine impurities and incorrect dosing instructions, highlighting the importance of robust manufacturing standards.
Patients are encouraged to verify their medications’ lot numbers and consult healthcare professionals before using any new prescription. For the latest updates on this recall or to report concerns, visit recalls-rappels.canada.ca or contact Health Canada’s Health Product and Food Branch Inspectorate at [email protected].