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Nra-amlodipine 5 mg tablets: one lot recalled

Official notice

7 Jul 2025

Last checked

7 Jul 2025

Critical riskHealth Canada

An official Health Canada notice concerns Nra-amlodipine 5 mg tablets: one lot recalled. 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. Published 2025-07-07.

What to do now

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 info@norapharma.ca. 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.

Recall number

77675

Official notice

2025-07-07

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

recalled

Recall Numbers

77675

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Affected products

Product 1

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

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Nra-amlodipine 5 MG Tablets, Nra-amlodipine 5 MG Din 02476460.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

App estimate

critical

Recall details

Recall number

77675

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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