Nitrosamine impurities in medications: Recalls 

On this page

• What you should do
• ARB recalls
• Ranitidine recalls
• Nizatidine recalls
• Metformin recalls
• Varenicline recalls
• Orphenadrine recalls
• Amitriptyline recalls
• Propranolol recalls
• Quinapril recalls
• Acyclovir recalls

What you should do

If a drug is recalled, you shouldn't stop taking your prescription medications until you:

• talk to your health care provider first and
• obtain an alternative treatment

Going without treatment for a medical condition may pose a greater health risk than potential nitrosamine exposure.

Speak to your pharmacist to see if the lot of medication you're taking is part of the recall.

You're encouraged to report a side effect to a drug or complaint to Health Canada.

ARBs recalls

Sartans or angiotensin II receptor blockers (ARBs)

If you're taking an ARB that has been recalled, you should:

• Continue taking your medication unless your health care provider has advised you to stop.
• Contact your health care provider:
  • to discuss treatment options if you're using a recalled product
  • if you have taken a recalled product in the past and are concerned about your health

Some ARBs have been recalled due to the presence of, or potential for, nitrosamine impurities.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not affect Canadian products.

Communications related to ARB recalls:

• Auro Pharma Inc. voluntarily recalls one lot of Auro-Irbesartan HCT tablets because of nitrosamine impurity (information update April 4, 2019)
• Pro Doc Limitée voluntarily recalls two lots of irbesartan drugs because of nitrosamine impurity (information update, March 14, 2019)
• Multiple Losartan-containing drugs voluntarily recalled because of potential for nitrosamine impurity (information update March 9, 2019)
• Health Canada releases test results of certain sartan drugs (information update December 20, 2018)
• Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity (information update November 28, 2018)
• Health Canada finds Zhejiang Huahai Pharmaceuticals site non-compliant with requirements for the manufacture of drug ingredients (information update October 2, 2018)
• Health Canada advises of a second impurity linked to recalled valsartan drugs (information update September 13, 2018)
• Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA (information update September 10, 2018)
• Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution (information update August 18, 2018)
• Several drugs containing valsartan being recalled due to contamination with a potential carcinogen (advisory July 9, 2018)

Ranitidine recalls

Ranitidine

If you're taking a ranitidine product, you should:

• Talk to your doctor or pharmacist as soon as you can about non-ranitidine treatment options that are right for you.
• Many alternative prescription and over-the-counter drug options in Canada have the same or similar uses as ranitidine.
• Continue taking your prescription or over-the-counter ranitidine drug, even if it has been recalled, unless you have obtained alternative treatment from your health care provider.
• The risk of not treating your condition may be greater than the risk from NDMA exposure.
• Contact your health care provider if you have taken a ranitidine product and have concerns about your health.

Some ranitidine products have been recalled due to the presence of or potential for nitrosamine impurities

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not affect Canadian products.

The following ranitidine products have been recalled in Canada.

Communications related to ranitidine recalls:

• Health Canada assessing NDMA in ranitidine
• Recalls for ranitidine products

Nizatidine recalls

If you're taking a recalled nizatidine product, you should:

• Check the lot number on your nizatidine product, or contact your pharmacist, to determine whether any of your product is subject to this recall.
• Individuals taking a prescription nizatidine drug, including a recalled product, should not stop taking it unless they have spoken to their health care provider and obtained alternative treatment, as the risk of not treating the condition may be greater than the risk related to NDMA exposure
• Contact your health care provider if you have taken a nizatidine product and have concerns about your health.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not impact Canadian products.

Some nizatidine products have been recalled due to the presence of nitrosamine impurities.

Communications related to nizatidine recall:

• Axid (nizatidine) drug recalled due to presence of NDMA

Metformin recalls

Metformin

You should not stop taking your metformin drug without first discussing options with your health care provider. The risk of not having adequate diabetes treatment outweighs the risk from NDMA exposure.

Stopping metformin could lead to uncontrolled diabetes, which can cause some serious health problems.

For example, high blood sugars can result in:

• dizziness
• irritability
• drowsiness
• blurred vision
• unintended weight loss
• increased thirst and urination
• excessive hunger and fatigue

Very high blood sugars can also cause:

• vomiting
• diarrhea
• agitation
• confusion
• dehydration
• a coma

Longer-term health impacts include heart disease, nerve problems, kidney damage, blindness and amputations.

Contact your health care provider:

• to discuss treatment options if you're using a recalled product
• if you have taken a recalled product in the past and are concerned about your health

Some metformin products have been recalled due to the presence of, or potential for, nitrosamine impurities.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not impact Canadian products.

Communications related to metformin recalls:

• Health Canada evaluating NDMA in metformin drugs (December 5, 2019)
• Certain Metformin diabetes drugs recalled due to the presence or possible presence of NDMA (February 5, 2020)

Varenicline recalls

Varenicline

If you're taking a varenicline drug that has been recalled, you should:

• Continue taking your medication unless your health care provider has advised you to stop.
• Contact your health care provider:
  • to discuss treatment options if you're using a recalled product
  • if you have taken a recalled product in the past and are concerned about your health

Some varenicline products have been recalled due to the presence of, or potential for, nitrosamine impurities.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not impact Canadian products. Recall is still outstanding for a single lot from Pfizer, please refer to the Dear Health Care Professional letter for more details.

Communications related to varenicline recalls:

• Dear Health Care Professional Letter (June 30, 2021)

Orphenadrine recalls

Orphenadrine

If you're taking an orphenadrine drug that has been recalled, you should:

• Consider switching to an alternative medication
• Contact your health care provider:
  • to discuss alternative treatment options
  • if you have taken a recalled product in the past and are concerned about your health

Some orphenadrine products have been recalled due to the presence of or potential for nitrosamine impurities.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not affect Canadian products.

Communications related to orphenadrine recalls:

• SteriMax Inc. recalls OrfenAce tablets (April 16, 2021)

Amitriptyline recalls

Amitriptyline

If you're taking an amitriptyline drug that has been recalled, you should:

• Continue taking your medication as there is no immediate risk in continuing to take the recalled medication. Stopping amitriptyline may lead to mild withdrawal symptoms.
• Contact your health care provider:
  • to discuss treatment options if you're using a recalled product
  • if you have taken a recalled product in the past and are concerned about your health

Some amitriptyline products have been recalled due to the presence of or potential for nitrosamine impurities.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not affect Canadian products.

Communications related to amitriptyline recalls:

• Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity (January 26, 2022)

Propranolol recalls

Propranolol

If you're taking a propranolol drug that has been recalled, you should:

• Continue taking your medication unless you have been advised to stop by your health care provider as not treating your condition poses a greater health risk
• Contact your health care provider:
  • to discuss treatment options if you're using a recalled product. While there are no other companies marketing extended release propranolol in Canada, immediate release propranolol products continue to be available, along with other treatment options.
  • if you have taken a recalled product in the past and are concerned about your health

Some propranolol products have been recalled due to the presence of or potential for nitrosamine impurities.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not affect Canadian products.

Communications related to propranolol recalls:

• Pfizer recalls Inderal-LA capsules (March 1, 2022)

Quinapril recalls

Quinapril

If you're taking a quinapril drug that has been recalled, you should:

• Continue taking your medication unless you have been advised to stop by your health care provider as not treating your condition may pose a greater health risk
• Contact your health care provider:
  • to discuss treatment options if you're using a recalled product
  • if you have taken a recalled product in the past and are concerned about your health

Some quinapril products have been recalled due to the presence of, or potential for, nitrosamine impurities.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not affect Canadian products.

Communications related to quinapril recalls:

• Pfizer recalls Accupril and Accuretic tablets (April 21, 2022)

Acyclovir recalls

Acyclovir

If you're taking an acyclovir drug that has been recalled, you should:

• Continue taking your medication unless you have been advised to stop by your health care provider as not treating your condition may pose a greater health risk.
• Talk to your health care provider if you are taking a recalled product and are concerned about your health.

Some acyclovir products have been recalled due to the presence of, or potential for, nitrosamine impurities.

Products not on this list have not been recalled in Canada. Recalls taking place in other countries may not affect Canadian products.

List of acyclovir drugs being recalled in Canada

Company	Product Name	DIN	Strength	Lot	Expiry
Apotex Inc.	Apo-Acyclovir 200 mg	02207621	200 mg	RH9369	08/2022
Apotex Inc.	Apo-Acyclovir 200 mg	02207621	200 mg	TF4466	08/2024
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	800 mg	TE5062	06/2023
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	800 mg	TH6119	12/2023
Apotex Inc.	Apo-Acyclovir 200 mg	02207621	200 mg	RH9368	08/2022
Apotex Inc.	Apo-Acyclovir 200 mg	02207621	200 mg	RH9370	08/2022
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	800 mg	RP8516	07/2022
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	800 mg	RP8517	07/2022
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	800 mg	RT8943	07/2022

Communications related to acyclovir recalls:

• Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity (July 28, 2022)