Canadians taking MAR-Amlodipine 5 mg should check their prescription bottles after two lots were recalled because some containers may include the wrong medication. Health Canada says affected bottles could contain midodrine 2.5 mg tablets instead of the blood pressure medicine shown on the label.
The recall involves MAR-Amlodipine 5 mg tablets with Drug Identification Number 02371715, lot numbers 2472021 and 2472021A, and an expiry date of July 2027. The medicine is manufactured by Marcan Pharmaceuticals Inc.
Patients should not assume that every bottle from these lots contains the wrong tablets. However, anyone with an affected bottle should inspect the shape and markings of each tablet before taking another dose.
How to identify the affected tablets
The correct MAR-Amlodipine 5 mg tablet is white or off-white, flat and eight-sided. It has a score line across the middle, with the markings “210” and “5” on one side. The other side is blank.
The midodrine 2.5 mg tablet that may have been placed in some bottles looks noticeably different. It is white and round, carries the marking “M2” on one side and has a score line on the other.
Immediate safety step: Do not take any round tablet found inside a MAR-Amlodipine 5 mg bottle. Return the bottle to the pharmacy and request a replacement.
Why taking the wrong medicine can be dangerous
Amlodipine and midodrine are prescribed for very different blood pressure conditions. Amlodipine helps lower high blood pressure and is also used to manage certain forms of chest pain. MAR-Amlodipine may be prescribed to adults and children aged six and older.
Midodrine has the opposite purpose. It is used to raise blood pressure in people experiencing abnormally low blood pressure. Accidentally taking midodrine instead of amlodipine could therefore leave a patient’s high blood pressure untreated while causing an additional increase in blood pressure.
Health Canada warns that the medication error could lead to dizziness, fainting, a slow heartbeat, dangerously high blood pressure or organ damage. Some people may have elevated blood pressure without immediately noticing symptoms, which makes a visual tablet check particularly important.
The potential effects can differ depending on a patient’s age, medical history and other medications. People with conditions such as glaucoma, hyperthyroidism or pheochromocytoma may face additional concerns if midodrine is taken by mistake.
Children may be more vulnerable to serious effects from an incorrect dose. Parents and caregivers should check the tablet shape and markings carefully rather than relying only on the prescription label.
What patients should do now
Start by comparing the DIN, lot number and expiry date on the prescription bottle with the recalled product information. Then inspect the tablets in a well-lit area. Correct tablets should be eight-sided, while the unwanted midodrine tablets are round.
- Do not take any tablet that is round or marked “M2.”
- Return a bottle containing unusual tablets to the dispensing pharmacy.
- Ask a pharmacist to inspect the medication when the tablet identity is unclear.
- Do not stop prescribed treatment without speaking to a pharmacist or health care professional.
Health Canada advises patients who cannot obtain an immediate replacement to continue taking their medication as directed, provided they take only the correct eight-sided tablets and avoid every round tablet.
The official Health Canada MAR-Amlodipine recall notice contains the full product description and instructions for reporting a health-product concern.
Symptoms that require urgent medical attention
Anyone who may have taken a round tablet should contact a health care professional. Health Canada says patients should call 911 if they experience dizziness, unusually high blood pressure or a slow heartbeat.
Emergency medical attention is also needed for chest pain, a sudden severe headache, difficulty speaking, or a sudden inability to move or feel part of the body. These symptoms should not be monitored at home while waiting to see whether they improve.
What the recall means for pharmacies
Pharmacists and other health professionals have been asked to inspect bottles labelled MAR-Amlodipine 5 mg before dispensing them. Any unexpected round tablets or unusual packaging should be reported to Marcan Pharmaceuticals and Health Canada.
Marcan Pharmaceuticals can be contacted at 1-855-627-2261 or info@marcanpharma.com for questions related to the recall.
The incident highlights why patients should become familiar with the usual appearance of medicines they take regularly. Packaging checks are important, but the shape, colour and imprint on a tablet can provide an additional warning when a dispensing or manufacturing mix-up occurs.
A similar quality issue involving another blood pressure medicine shows how regulators classify and communicate medication defects. More details are available in this report on an FDA blood pressure medication recall .
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