Information update

Ranitidine products recalled because of a nitrosamine impurity

Last updated

Summary

Product
Over-the-counter and prescription ranitidine drugs (LATEST UPDATE: March 11, 2022 – Pharmascience Inc. recall)
Issue
Health products - Product safety
What to do

Contact your health care provider to discuss other treatment options or if you have taken a ranitidine product and have concerns about your health.

Affected products

The following is a list of ranitidine products being recalled in Canada at this time. Please note that they are listed alphabetically by company:
Company Product Name/Active Pharmaceutical Ingredient (API) DIN Strength Lot Date added
Pharmascience Inc. ATOMA maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 629744F 2022-03-11
Pharmascience Inc. ATOMA maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632058H 2022-03-11
Pharmascience Inc. Compliments maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632043B 2022-03-11
Pharmascience Inc. Compliments maximum strength acid reducer without prescription cool mint (24 tablets) 02293471 150 mg 629973A 2022-03-11
Pharmascience Inc. CO-OP Care+ maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 629744C 2022-03-11
Pharmascience Inc. Health One maximum strength acid reducer without prescription (32 tablets) 02293471 150 mg 629744J 2022-03-11
Pharmascience Inc. Health One maximum strength acid reducer without prescription (32 tablets) 02293471 150 mg 632043H 2022-03-11
Pharmascience Inc. Life Brand maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 629744H 2022-03-11
Pharmascience Inc. Life Brand maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632058I 2022-03-11
Pharmascience Inc. Life Brand maximum strength acid reducer without prescription cool mint (48 tablets) 02293471 150 mg 629974B 2022-03-11
Pharmascience Inc. Life Brand maximum strength acid reducer without prescription cool mint (24 tablets) 02293471 150 mg 629974A 2022-03-11
Pharmascience Inc. Option+ maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 629744G 2022-03-11
Pharmascience Inc. Option+ maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632043D 2022-03-11
Pharmascience Inc. Option+ maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632043E 2022-03-11
Pharmascience Inc. Option+ maximum strength acid reducer without prescription (8 tablets) 02293471 150 mg 632058A 2022-03-11
Pharmascience Inc. Option+ maximum strength acid reducer without prescription cool mint (24 tablets) 02293471 150 mg 629973B 2022-03-11
Pharmascience Inc. Option+ maximum strength acid reducer without prescription cool mint (24 tablets) 02293471 150 mg 631893C 2022-03-11
Pharmascience Inc. PERSONNELLE maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 629744E 2022-03-11
Pharmascience Inc. PERSONNELLE maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632043A 2022-03-11
Pharmascience Inc. PERSONNELLE maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632043F 2022-03-11
Pharmascience Inc. PERSONNELLE maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632058J 2022-03-11
Pharmascience Inc. PERSONNELLE maximum strength acid reducer without prescription (8 tablets) 02293471 150 mg 629744B 2022-03-11
Pharmascience Inc. PERSONNELLE maximum strength acid reducer without prescription (8 tablets) 02293471 150 mg 632058B 2022-03-11
Pharmascience Inc. PERSONNELLE maximum strength acid reducer without prescription cool mint (24 tablets) 02293471 150 mg 629973C 2022-03-11
Pharmascience Inc. PERSONNELLE maximum strength acid reducer without prescription cool mint (48 tablets) 02293471 150 mg 629973D 2022-03-11
Pharmascience Inc. PHARMASAVE maximum strength acid reducer without prescription (8 tablets) 02293471 150 mg 629744A 2022-03-11
Pharmascience Inc. Rexall maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 629744I 2022-03-11
Pharmascience Inc. Rexall maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632043G 2022-03-11
Pharmascience Inc. Rexall maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 632058G 2022-03-11
Pharmascience Inc. Rexall maximum strength acid reducer without prescription (8 tablets) 02293471 150 mg 632058D 2022-03-11
Apotex Inc. Acid Reducer (ranitidine) sold under the brand names Equate and Selection 02296160 150 mg All lots 2019-09-25
Apotex Inc. Apo-Ranitidine Oral Solution 02280833 15 mg/mL All lots 2019-09-25
Apotex Inc. Apo-Ranitidine Tablet 150 mg 00733059 150 mg All lots 2019-09-25
Apotex Inc. Apo-Ranitidine Tablet 300 mg 00733067 300 mg All lots 2019-09-25
Dominion Pharmacal Maximum Strength Acid Reducer Without Prescription (ranitidine) sold under the brand name Personnelle 02407523 150 mg All lots 2019-10-25
Laboratoire Riva Inc. Riva-Ranitidine 150 02247814 150 mg All lots 2019-10-25
Laboratoire Riva Inc. Riva-Ranitidine 300 02247815 300 mg All lots 2019-10-25
Laboratoire Riva Inc. Acid Reducer (ranitidine) sold under the brand names Biomedic, Circle K and Option+ 02452464 75 mg All lots 2019-10-25
Pharmascience Inc. BIOMEDIC Acid Reducer (30 tablets) 02247551 75 mg 632952I 2021-12-03
Pharmascience Inc. Life Brand Acid Reducer (30 tablets) 02247551 75 mg 632952K 2021-12-03
Pharmascience Inc. OPTION+ Acid Reducer (10 tablets) 02247551 75 mg 632952B 2021-12-03
Pharmascience Inc. OPTION+ Acid Reducer (40 tablets) 02247551 75 mg 633694B 2021-12-03
Pharmascience Inc. Personnelle Acid Reducer (10 tablets) 02247551 75 mg 632952D 2021-12-03
Pharmascience Inc. ATOMA maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 627765H 2021-12-03
Pharmascience Inc. BIOMEDIC maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 627765I 2021-12-03
Pharmascience Inc. BIOMEDIC maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 628471C 2021-12-03
Pharmascience Inc. Compliments maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 628471D 2021-12-03
Pharmascience Inc. CO-OP Care+ maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 627765D 2021-12-03
Pharmascience Inc. Health One maximum strength acid reducer without prescription (32 tablets) 02293471 150 mg 628471A 2021-12-03
Pharmascience Inc. London Drugs maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 627765E 2021-12-03
Pharmascience Inc. Option+ maximum strength acid reducer without prescription (8 tablets) 02293471 150 mg 627765B 2021-12-03
Pharmascience Inc. Option+ maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 627765G 2021-12-03
Pharmascience Inc. PHARMASAVE maximum strength acid reducer without prescription (8 tablets) 02293471 150 mg 627765C 2021-12-03
Pharmascience Inc. PHARMASAVE maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 628471B 2021-12-03
Pharmascience Inc. Rexall maximum strength acid reducer without prescription (8 tablets) 02293471 150 mg 627765A 2021-12-03
Pharmascience Inc. Rexall maximum strength acid reducer without prescription (24 tablets) 02293471 150 mg 627765F 2021-12-03
Pharmascience Inc. Compliments Maximum Strength Acid Reducer (50 tablets) 02293471 150mg 628453 2021-02-05
Pharmascience Inc. CO-OP CARE + Maximum Strength Acid Reducer (24 tablets) 02293471 150mg 628308F 2021-02-05
Pharmascience Inc. Life Brand Maximum Strength Acid Reducer (50 tablets) 02293471 150mg 628429 2021-02-05
Pharmascience Inc. Life Brand Maximum Strength Acid Reducer (24 tablets) 02293471 150mg 628308E 2021-02-05
Pharmascience Inc. Option+ Maximum Strength Acid Reducer (8 tablets) 02293471 150mg 628308B 2021-02-05
Pharmascience Inc. Personnelle Maximum Strength Acid Reducer (50 tablets) 02293471 150mg 628442 2021-02-05
Pharmascience Inc. PERSONNEL Maximum Strength Acid Reducer (8 tablets) 02293471 150mg 628308A
628308C
2021-02-05
Pharmascience Inc. PERSONNEL Maximum Strength Acid Reducer (24 tablets) 02293471 150mg 628308D 2021-02-05
Pharmascience Inc. pms-RANITIDINE 02242453 150mg 626718
623633
624871
626714
2021-02-05
Pharmascience Inc. ATOMA Acid Reducer (10 tablets) 02247551 75 mg 621791O 2021-01-30
Pharmascience Inc. ATOMA Acid Reducer (30 tablets) 02247551 75 mg 621791X 2021-01-30
Pharmascience Inc. BIOMEDIC Acid Reducer (30 tablets) 02247551 75 mg 621791K 2021-01-30
Pharmascience Inc. BIOMEDIC Acid Reducer (30 tablets) 02247551 75 mg 621791U 2021-01-30
Pharmascience Inc. Compliments Acid Reducer (60 tablets) 02247551 75 mg 621791D 2021-01-30
Pharmascience Inc. Life Brand Acid Reducer (10 tablets) 02247551 75 mg 621791G 2021-01-30
Pharmascience Inc. Life Brand Acid Reducer (10 tablets) 02247551 75 mg 621791P 2021-01-30
Pharmascience Inc. Life Brand Acid Reducer (30 tablets) 02247551 75 mg 621791Q 2021-01-30
Pharmascience Inc. Life Brand Acid Reducer (60 tablets) 02247551 75 mg 621791AA 2021-01-30
Pharmascience Inc. London Drugs Acid Reducer (30 tablets) 02247551 75 mg 621791R 2021-01-30
Pharmascience Inc. OPTION+ Acid Reducer (10 tablets) 02247551 75 mg 621791H 2021-01-30
Pharmascience Inc. OPTION+ Acid Reducer (10 tablets) 02247551 75 mg 621791T 2021-01-30
Pharmascience Inc. OPTION+ Acid Reducer (40 tablets) 02247551 75 mg 621791Y 2021-01-30
Pharmascience Inc. Personnelle Acid Reducer (10 tablets) 02247551 75 mg 621791A 2021-01-30
Pharmascience Inc. Personnelle Acid Reducer (10 tablets) 02247551 75 mg 621791N 2021-01-30
Pharmascience Inc. Personnelle Acid Reducer (40 tablets) 02247551 75 mg 621791I 2021-01-30
Pharmascience Inc. Personnelle Acid Reducer (40 tablets) 02247551 75 mg 621791Z 2021-01-30
Pharmascience Inc. PHARMASAVE Acid Reducer (30 tablets) 02247551 75 mg 621791V 2021-01-30
Pharmascience Inc. Rexall Acid Reducer (60 tablets) 02247551 75 mg 621791S 2021-01-30
Pharmascience Inc. Rexall Acid Reducer (10 tablets) 02247551 75 mg 621791F 2021-01-30
Pharmascience Inc. Rexall Acid Reducer (10 tablets) 02247551 75 mg 621791M 2021-01-30
Pharmascience Inc. Rexall Acid Reducer (30 tablets) 02247551 75 mg 621791E 2021-01-30
Pharmascience Inc. Rexall Acid Reducer (30 tablets) 02247551 75 mg 621791W 2021-01-30
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name Compliments 02247551 75 mg 619254I 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name EXACT 02247551 75 mg 619254G 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name EXACT 02247551 75 mg 619254B 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name Life Brand 02247551 75 mg 624735C 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name Life Brand 02247551 75 mg 627539C 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name Life Brand 02247551 75 mg 619254H 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name Life Brand 02247551 75 mg 619254C 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name OPTION+ 02247551 75 mg 624735B 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name OPTION+ 02247551 75 mg 627539B 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name Personnelle 02247551 75 mg 624735A 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name Personnelle 02247551 75 mg 619254K 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name Personnelle 02247551 75 mg 627539A 2021-01-08
Pharmascience Inc. Acid Reducer (raniditine) sold under the brand name PHARMASAVE 02247551 75 mg 619254J 2021-01-08
Pharmascience Inc. PMS-Ranitidine 150 mg 02242453 150 mg 619003 2020-08-31
Pharmascience Inc. PMS-Ranitidine 150 mg 02242453 150 mg All lots 2019-10-25
Pharmascience Inc. PMS-Ranitidine 300 mg 02242454 300 mg Al lots 2019-10-25
Pharmascience Inc. Acid Reducer (ranitidine) sold under the brand names Atoma, Biomedic, Compliments, Exact, Life Brand, London Drugs, Option+, Personnelle, Pharmasave, Preferred Pharmacy, Rexall and Selection 02247551 75 mg All lots 2019-10-25
Pharmascience Inc. Maximum Strength Acid Reducer Without Prescription (ranitidine) sold under the brand names Atoma, Biomedic, Compliments, Co-op Care+, Equate, Exact, Health One, Kirkland Signature, London Drugs, Option+, Personnelle, Pharmasave, Rexall and Selection 02293471 150 mg All lots 2019-10-25
Pharmascience Inc. Acid Reducer (ranitidine) sold under the brand names Exact and Life Brand 02400103 150 mg All lots 2019-10-25
Pro Doc Limitée Ranitidine - 150 mg 00740748 150 mg All lots 2019-09-25
Pro Doc Limitée Ranitidine - 300 mg 00740756 300 mg All lots 2019-09-25
Ranbaxy Pharmaceuticals Canada Inc. Ran-Ranitidine 02336480 150 mg All lots 2019-10-30
Ranbaxy Pharmaceuticals Canada Inc. Ran-Ranitidine 02336502 300 mg All lots 2019-10-30
Sandoz Canada Sandoz Ranitidine 02243229 150 mg All lots 2019-09-17
Sandoz Canada Sandoz Ranitidine 02243230 300 mg All lots 2019-09-17
Sanis Health Inc. Ranitidine 02353016 150 mg All lots 2019-09-25
Sanis Health Inc. Ranitidine 02353024 300 mg All lots 2019-09-25
Sanofi Consumer Health Inc. Zantac (ranitidine) 02230287 75 mg All lots 2019-10-18
Sanofi Consumer Health Inc. Zantac Maximum Strength Non-Prescription (ranitidine) 02277301 150 mg All lots 2019-10-18
Sivem Pharmaceuticals ULC Ranitidine 02385953 150 mg NP4179
NP4183
NP4184
NP5656
NP5657
NT2721
NT2722
NT2724
NT2757
NT2762
NT2763
NT2764
NT2765
PJ2434
PJ2435
PV6243
PV6244
PV6245
2019-09-25
Sivem Pharmaceuticals ULC Ranitidine 02385953 150 mg K46484
K46485
K48440
K48679
K50204
K50206
K50207
K50590
K50594
K50677
K50908
K50925
K50928
K50932
K50935
K51080
2019-10-18
Sivem Pharmaceuticals ULC Ranitidine 02385961 300 mg NP4177
NP4180
NT1365
PX8854
2019-09-25
Sivem Pharmaceuticals ULC Ranitidine 02385961 300 mg

K50624
K50941
K50947
K50950

2019-10-18
Teva Canada Limited Act Ranitidine 02248570 150 mg All lots 2019-10-18
Teva Canada Limited Act Ranitidine 02248571 300 mg All lots 2019-10-18
Vita Health Products Inc. Acid Reducer (ranitidine) sold under the brand names Equate, iPharma, Stanley and Western Family 02298740 75 mg All lots 2019-10-25
Vita Health Products Inc. Maximum Strength Acid Reducer (ranitidine) sold under the brand names Equate, iPharma and Western Family 02298902 150 mg All lots 2019-10-25

Issue

UPDATE: March 11, 2022 – Pharmascience Inc. recalls 30 lots of 150 mg over-the-counter ranitidine packaged in blister packs

Pharmascience Inc. is recalling 30 lots of over-the-counter ranitidine drugs (150 mg tablets), packaged in blister packs, after tests found NDMA, a nitrosamine impurity, above the acceptable level in some lots. The products are sold under various private labels. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE - December 3, 2021 - Pharmascience Inc. recalls certain lots of over-the-counter ranitidine

Pharmascience Inc. is recalling 18 lots of over-the-counter ranitidine drugs (75 mg and 150 mg tablets) after tests found NDMA, a nitrosamine impurity, close to and above the acceptable level. The products are sold under various private labels. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE: February 5, 2021 - Pharmascience Inc. recalls certain lots of prescription and over-the-counter ranitidine as a precaution

Pharmascience Inc. is recalling 13 lots of prescription and over-the-counter ranitidine drugs (150 mg tablets) after tests found NDMA, a nitrosamine impurity, at below but close to the accepted level. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE: January 30, 2021 - Pharmascience Inc. recalls additional lots of over-the-counter ranitidine

Pharmascience Inc. is recalling 23 additional lots of its over-the-counter ranitidine drugs (75 mg tablets) after tests found NDMA, a nitrosamine impurity, above accepted levels. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE: January 8, 2021 - Pharmascience Inc. recalls certain lots of over-the-counter ranitidine

Pharmascience Inc. is recalling 13 additional lots of its store-brand over-the-counter ranitidine products (75 mg strength tablet) after tests found NDMA, a nitrosamine impurity, above accepted levels. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE: August 31, 2020 - Pharmascience Inc. recalls one lot of PMS-Ranitidine as a precaution

Pharmascience Inc. is recalling one lot of prescription PMS-Ranitidine (150 mg strength tablet) as a precaution after tests found NDMA, a nitrosamine impurity, at close to the accepted level. Please refer to the Affected Products table for detailed information on the recalled lot (lot 619003).

Health Canada recently provided an update on the status of ranitidine drugs in Canada. Companies wishing to resume sales have been permitted to do so provided they test every batch of ranitidine product before releasing it and continue to regularly retest the batch throughout its shelf life, to demonstrate that products do not contain higher than accepted levels of NDMA.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE: October 30, 2019 - Ranbaxy Pharmaceuticals Canada Inc. recalls prescription ranitidine products as a precaution; request to stop distribution remains in place while Health Canada continues to assess NDMA

Ranbaxy Pharmaceuticals Canada Inc. is recalling all lots of its prescription ranitidine products from the Canadian market as a precautionary measure. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE: October 25, 2019 - Additional ranitidine products recalled as a precautionary measure; request to stop distribution remains in place while Health Canada continues to assess NDMA

Dominion Pharmacal, Laboratoire Riva Inc., Pharmascience Inc. and Vita Health Inc. are recalling all lots of their prescription and over-the-counter ranitidine products from the Canadian market as a precautionary measure. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE: October 18, 2019 - Additional ranitidine products recalled, including Zantac; request to stop distribution remains in place while Health Canada continues to assess NDMA

Additional prescription and over-the-counter ranitidine drugs, including Zantac, are being recalled by Sanofi Consumer Health Inc., Sivem Pharmaceuticals ULC and Teva Canada Limited because they may contain the impurity N-nitrosodimethylamine (NDMA) above acceptable levels. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

UPDATE: September 25, 2019 - Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; additional products being recalled

Additional ranitidine drugs are being recalled by four companies: Apotex Inc., Pro Doc Limitée, Sanis Health Inc., and Sivem Pharmaceuticals ULC. The lots are being recalled as they may have been manufactured using an active pharmaceutical ingredient containing an impurity, N-nitrosodimethylamine (NDMA), above acceptable levels. Please refer to the Affected Products table for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

Original Information Update: September 17, 2019 - Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; some products being recalled

OTTAWA - Health Canada recently informed Canadians that it is assessing the issue of an impurity called N-nitrosodimethylamine (NDMA) detected in some ranitidine drugs. Current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer. As a result, and at Health Canada's request, companies marketing ranitidine products in Canada have stopped any further distribution until evidence is provided to demonstrate that they do not contain NDMA above acceptable levels.

The request to stop distribution means that the existing stock of ranitidine products currently available in pharmacies or at retail stores may continue to be sold. This is different from a recall, since products that are being recalled can no longer be sold.

This is an interim, precautionary measure as Health Canada continues to gather information from companies and to assess the issue with other international regulators.

One company, Sandoz Canada, is recalling its oral prescription products in Canada and other countries after testing identified levels of NDMA above what is considered acceptable if the drug were to be taken over a lifetime. Should any additional recalls be deemed necessary, Health Canada will update the table and inform Canadians.

Ranitidine is available in Canada over-the-counter (for example, under the brand name Zantac and as generics) and by prescription (as generics). Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach. Prescription ranitidine drugs are used to reduce stomach acid for the treatment and prevention of various conditions, such as heartburn, ulcers of the stomach and intestines, and gastroesophageal reflux disease (commonly known as GERD).

NDMA is classified as a probable human carcinogen, which means long-term exposure to levels above what is considered safe could increase the risk of cancer. We are all exposed to low levels of NDMA in some foods (such as meats, dairy products and vegetables) and in drinking water. NDMA is not expected to cause harm when ingested at very low levels.

Health Canada continues to gather and share information with other regulators, including the U.S. Food and Drug Administration and the European Medicines Agency, and with Canadian companies to better understand the issue and whether there may be a risk to Canadians. This includes conducting its own tests and assessing whether the results seen in laboratory tests present a human health risk. The Department will take action if a risk to Canadians is identified, and will continue to inform the public of new safety information.

Health Canada has been working to address the issue of NDMA and similar impurities, known as nitrosamines, found in certain "sartan" angiotensin receptor blocker (ARB) blood pressure medications since 2018. Health Canada continues to work closely with international regulatory partners to address the issue. This includes broadening its efforts to evaluate the potential for nitrosamines in drugs other than sartans and measures to address and prevent the impurities.

Who is affected

Consumers and patients who are taking a ranitidine drug.

What you should do

  • Talk to your doctor or pharmacist at your earliest convenience about alternative, non-ranitidine treatment options appropriate for your health circumstances. There are many prescription and over-the-counter drug alternatives in Canada that are authorized for the same or similar uses as ranitidine.
  • Individuals taking a prescription ranitidine 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 ranitidine product and you have concerns about your health.
  • Report any health product adverse events or complaints to Health Canada.

Canadians with questions about the recalls can contact

Related links:

Additional information

Details
Original published date:
Alert / recall type
Information update
Category
Health products
Companies
Published by
Health Canada
Audience
General public
Identification number
RA-59609
Media and public enquiries

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