OTTAWA, ON, July 5, 2025 –

Summary

• Product: NRA-Amlodipine 5 mg, DIN 02476460
• Issue: Health products – Product safety
• What to do: Inspect your NRA-Amlodipine 5 mg tablet bottles. The appropriate tablets are white or off-white and shaped like an octagon. If the bottle has any round tablets, which are the incorrect shape, or you aren’t sure, take the bottle back to the pharmacy for a replacement. If a replacement isn’t available right away, continue taking your medication as prescribed, but do not consume the round tablets because they are the incorrect medication. If you feel dizzy, have unusually low blood pressure, or experience slow heartbeats, speak with your doctor. If you can’t reach a doctor and are experiencing these symptoms, dial 911.

Affected products 

Issue 

Nora Pharma is recalling a specific batch of NRA-Amlodipine 5 mg tablets because some bottles might contain the incorrect tablets, identified as metoprolol succinate prolonged-release 12.5 mg tablets.

NRA-Amlodipine is used to treat high blood pressure and chest pain in adults and children between 6 and 17 years old. The tablets are octagonal, flat, white or off-white, and have a score in the center with ‘210’ and ‘5’ marked on one side.

The metoprolol succinate prolonged-release 12.5 mg tablets are round, white, and scored in the middle.

Metoprolol is also used to treat high blood pressure and chest pain; however, replacing amlodipine (5 mg) with metoprolol (12.5 mg) can cause severe side effects, including dangerously low blood pressure, trouble breathing, or an abnormally slow heart rate.

Patients with pre-existing conditions (like heart failure, asthma, severe peripheral arterial disease, pheochromocytoma, or diabetes) and those on other medications may experience different side effects with varying degrees of severity.

Children who take the wrong medication may be at greater risk of serious side effects and potential harm.

Health Canada is keeping tabs on the company’s recall and investigation, including how they are putting corrective and preventive actions in place to prevent the problem from happening again. If any new health risks are discovered, the Department will inform the public.

What you should do 

• Examine your medication bottle to confirm it only contains NRA-AMLODIPINE 5 mg tablets.
• • If your bottle contains any round tablets, which are not the correct shape, or if you’re unsure, return the bottle to your pharmacy for a replacement.
  • If you are unable to get a replacement immediately, continue to take your medication as directed, but do not take the round tablets as these are the wrong medication.
  • Consult your healthcare provider if you experience dizziness, unusually low blood pressure or slow heartbeats. If you cannot reach a healthcare provider and are experiencing these symptoms, dial 911.
• If you have questions regarding this recall, please contact Nora Pharma Inc.’s Quality Assurance Department at 450-904-2355 or via email at .
• Report any health product-related side effects or complaints to Health Canada.

Additional information for health professionals:

• Before dispensing NRA-AMLODIPINE 5 mg (amlodipine besylate), healthcare professionals like pharmacists should inspect the packages and bottles to ensure they don’t contain Metoprolol Succinate prolonged-release 12.5 mg tablets. Report any unusual bottles or other issues to the company and .

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SOURCE Health Canada (HC)

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