Public Advisory - NRA-Amlodipine 5 mg tablets: One lot recalled as some bottles may contain the wrong drug

OTTAWA, ON, July 5, 2025 /CNW/ -

Summary

• Product: NRA-Amlodipine 5 mg, DIN 02476460
• Issue: Health products - Product safety
• What to do: Check your bottle of NRA-Amlodipine 5 mg tablets. The correct tablets are white or off-white and octagonal. 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. Contact your health care professional if you are dizzy, have unusually low blood pressure or slow heartbeats. If you are unable to access a health care professional and you are experiencing these symptoms, call 911.

Affected products 

Product	NPN	Lot	Expiry
NRA-Amlodipine 5 mg	02476460	EM240229	2027-08

Issue 

Nora Pharma is recalling one lot of NRA-Amlodipine 5 mg tablets because some bottles may contain the wrong tablets, which have been identified as metoprolol succinate prolonged–release 12.5 mg tablets.

NRA-Amlodipine treats high blood pressure and chest pain in adults and children aged 6 to 17. The tablets are white or off-white, octagonal, flat, and scored in the middle with '210' and '5' on one side.

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

While metoprolol is also used to treat high blood pressure and chest pain, substituting amlodipine (5 mg) with metoprolol (12.5 mg) can lead to serious side effects such as dangerous blood pressure changes (especially dangerously low drops), difficulty breathing, or an abnormally slow heart rate.

Patients with other conditions (especially heart failure, asthma, severe peripheral arterial disease, pheochromocytoma, or diabetes) and those taking other medications could experience different side effects with varying levels of severity.

Children taking the wrong medication may face a higher risk of serious side effects and potential harm.

Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions to stop this issue from reoccurring. The Department will inform the public if any new health risks are identified.

What you should do 

• Check your medication bottle to ensure 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.
  • Contact your health care professional if you are dizzy, have unusually low blood pressure or slow heartbeats. If you are unable to access a health care professional and you are experiencing these symptoms, call 911.
• If you have questions about this recall, contact Nora Pharma Inc. by calling their Quality Assurance Department at 450-904-2355 or by emailing [email protected].
• Report any health product-related side effects or complaints to Health Canada.

Additional information for health professionals:

• Health care professionals, such as pharmacists, should check packages and bottles labelled NRA-AMLODIPINE 5 mg (amlodipine besylate) before dispensing to make sure they do not contain Metoprolol Succinate prolonged-release 12.5 mg tablets. Report any unusual bottles or other issues to the company and Health Canada.

Également disponible en français

SOURCE Health Canada (HC)

Media Enquiries: Health Canada, 613-957-2983, [email protected]; Public Enquiries: Health Canada, 866-225-0709, [email protected]