Nitrosamine impurities in medications: Recalls 

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What you should do

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

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:

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 impact Canadian products.

List of ARB medications recalled in Canada
Product name/Active
Pharmaceutical Ingredient
DIN Strength Lot # Date Recalled API Manufacturer
AURO-IRBESARTAN/HCT 02447878    150/12.5    mg IN1518001-A April 17, 2019 Aurobindo Pharma Limited, Unit-I
PRO DOC LIMITEE - IRBESARTAN 02365200   150 mg 604292 March 11, 2019 TEVA API India Ltd.
PRO DOC LIMITEE - IRBESARTAN 02365219   300 mg 601795 March 11, 2019 TEVA API India Ltd.
APO-LOSARTAN 02379058   25 mg NL1453 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02379058   25 mg NL1452 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02353504   50 mg NK1254 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02353504   50 mg NK1253 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02353512   100 mg NL1461 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02353512   100 mg NG2092 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02353512 1  00 mg NH5932 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02353512   100 mg NH5933 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02353512   100 mg NL1460 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN 02353512   100 mg NH5934 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371235   50/12.5 mg NL1441 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371235   50/12.5 mg NZ8848 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371235   50/12.5 mg NL1445 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371235   50/12.5 mg NZ8849 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371235   50/12.5 mg NZ8860 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371243   100/12.5 mg NG2087 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371243   100/12.5 mg NL1421 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371243   100/12.5 mg NG2086 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371243   100/12.5 mg NL1422 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371251   100/25 mg NL1429 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371251   100/25 mg NZ8846 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371251   100/25 mg NZ8847 March 8, 2019 Hetero Laboratories Limited Unit 1
APO-LOSARTAN/HCTZ 02371251   100/25 mg NZ8845 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309750   25 mg 498294 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309750   25 mg 605342 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309750   25 mg 611944 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309769   50 mg 498285 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309769   50 mg 600047 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309769   50 mg 600091 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309769   50 mg 603894 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309769   50 mg 612025 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309769   50 mg 612031 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309769   50 mg 612679 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309769   50 mg 616743 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309777   100 mg 498864 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309777   100 mg 602668 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309777   100 mg 603816 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309777   100 mg 605298 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309777   100 mg 605300 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309777   100 mg 613935 March 8, 2019 Hetero Laboratories Limited Unit 1
PMS-LOSARTAN 02309777   100 mg 613936 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394367   25 mg 498292 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394367   25 mg 605344 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394375   50 mg 498779 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394375   50 mg 600046 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394375   50 mg 603903 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394375   50 mg 498284 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394375   50 mg 603895 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394383   100 mg 499008 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394383   100 mg 605299 March 8, 2019 Hetero Laboratories Limited Unit 1
LOSARTAN (PRO DOC LIMITEE) 02394383   100 mg 605297 March 8, 2019 Hetero Laboratories Limited Unit 1
TEVA-LOSARTAN/HCTZ 02358263   50/12.5 mg 35344801A March 6, 2019 Hetero Laboratories Limited Unit 1
TEVA-LOSARTAN/HCTZ 02358263  50/12.5mg 35349397A March 6, 2019 Hetero Laboratories Limited Unit 1
MYLAN-VALSARTAN 02383527   40 mg All lots November 28, 2018 Mylan Laboratories Limited
MYLAN-VALSARTAN 02383535  80 mg All lots November 28, 2018 Mylan Laboratories Limited
MYLAN-VALSARTAN 02383543  160 mg All lots November 28, 2018 Mylan Laboratories Limited
MYLAN-VALSARTAN 02383551 3 20 mg All lots November 28, 2018 Mylan Laboratories Limited
TEVA-VALSARTAN/HCTZ TABLETS 02356996  80/12.5 mg 35211136A August 17, 2018 Zhejiang Huahai Pharmaceuticals
TEVA-VALSARTAN/HCTZ TABLETS 02357003  160/12.5 mg 35211335A August 17, 2018 Zhejiang Huahai Pharmaceuticals
TEVA-VALSARTAN/HCTZ TABLETS 02357003  160/12.5 mg 35211844R August 17, 2018 Zhejiang Huahai Pharmaceuticals
TEVA-VALSARTAN/HCTZ TABLETS 02357011  160/25 mg 35210937R August 17, 2018 Zhejiang Huahai Pharmaceuticals
TEVA-VALSARTAN/HCTZ TABLETS 02357011  160/25 mg 35210938R August 17, 2018 Zhejiang Huahai Pharmaceuticals
TEVA-VALSARTAN/HCTZ TABLETS 02357011  160/25 mg 35210939R August 17, 2018 Zhejiang Huahai Pharmaceuticals
TEVA-VALSARTAN/HCTZ TABLETS 02357011  160/25 mg 35210940R August 17, 2018 Zhejiang Huahai Pharmaceuticals
TEVA-VALSARTAN/HCTZ TABLETS 02357038 3 20/12.5 mg 35211546R August 17, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 40MG FC TABLETS 02337487   40 mg K47338 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 80MG FC TABLETS 02337495   80 mg K45370 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 80MG FC TABLETS 02337495   80 mg K47652 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 80MG FC TABLETS 02337495   80 mg K47653 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 80MG FC TABLETS 02337495   80mg K47654 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 160MG FC TABLETS 02337509  160 mg K39691 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 160MG FC TABLETS 02337509  160 mg K44167 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 160MG FC TABLETS 02337509 160 mg K47657 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 160MG FC TABLETS 02337509   160 mg K47658 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 320MG FC TABLETS 02337517   320 mg K44166 July 9, 2018 Zhejiang Huahai Pharmaceuticals
ACT-VALSARTAN 320MG FC TABLETS 02337517   320 mg K45371 July 9, 2018 Zhejiang Huahai Pharmaceuticals
PRO DOC LIMITEE VALSARTAN 40 MG 02367726   40 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
PRO DOC LIMITEE VALSARTAN 80 MG 02367734   80 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
PRO DOC LIMITEE VALSARTAN 160 MG 02367742   160 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
PRO DOC LIMITEE VALSARTAN 320 MG 02367750   320 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SANDOZ VALSARTAN 40 MG 02356740   40 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SANDOZ VALSARTAN 80 MG 02356759   80 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SANDOZ VALSARTAN 160 MG 02356767   160 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SANDOZ VALSARTAN 320 MG 02356775   320 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SANIS VALSARTAN 40 MG 02366940   40 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SANIS VALSARTAN 80 MG 02366959   80 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SANIS VALSARTAN 160 MG 02366967   160 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SANIS VALSARTAN 320 MG 02366975   320 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SIVEM PHARMACEUTICAL ULC VALSARTAN 40 MG 02384523   40 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SIVEM PHARMACEUTICAL ULC VALSARTAN 80 MG 02384531  80 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SIVEM PHARMACEUTICAL ULC VALSARTAN 160 MG 02384558  160 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
SIVEM PHARMACEUTICAL ULC VALSARTAN 320 MG 02384566  320 mg All lots July 9, 2018 Zhejiang Huahai Pharmaceuticals
TEVA-VALSARTAN/HCTZ TABLETS PP 30s 02357046  320/25 mg 35212731R July 9, 2018 Zhejiang Huahai Pharmaceuticals

Communications related to ARB recalls:

Ranitidine recalls

Ranitidine

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

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 impact Canadian products.

The following ranitidine products have been recalled in Canada.

List of ranitidine products in Canada that have been recalled
Company Product Name/Active Pharmaceutical Ingredient (API) DIN Strength Lot Date added
Apotex Inc. Acid Reducer (ranitidine) sold under the brand names Equate and Selection 02296160  150 mg All lots September 25, 2019
Apotex Inc. Apo-Ranitidine Oral Solution 02280833  15 mg/mL All lots September 25, 2019
Apotex Inc. Apo-Ranitidine Tablet 150mg 00733059  150 mg All lots September 25, 2019
Apotex Inc. Apo-Ranitidine Tablet 300mg 00733067  300 mg All lots September 25, 2019
Dominion Pharmacal Maximum Strength Acid Reducer Without Prescription (ranitidine) sold under the brand name Personnelle 02407523  150 mg All lots October 25, 2019
Laboratoire Riva Inc. Riva-Ranitidine 150 02247814  150 mg All lots October 25, 2019
Laboratoire Riva Inc. Riva-Ranitidine 300 02247815  300 mg All lots October 25, 2019
Laboratoire Riva Inc. Acid Reducer (ranitidine) sold under the brand names Biomedic, Circle K and Option+ 02452464  75 mg All lots October 25, 2019
Pharmascience Inc. PMS-Ranitidine 150 mg 02242453  150 mg All lots October 25, 2019
Pharmascience Inc. PMS-Ranitidine 300 mg 02242454  300 mg Al lots October 25, 2019
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 October 25, 2019
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 October 25, 2019
Pharmascience Inc. Acid Reducer (ranitidine) sold under the brand names Exact and Life Brand 02400103  150 mg All lots October 25, 2019
Pro Doc Limitée Ranitidine - 150 00740748 150 mg All lots September 25, 2019
Pro Doc Limitée Ranitidine - 300 00740756  300 mg All lots September 25, 2019
Ranbaxy Pharmaceuticals Canada Inc. Ran-Ranitidine 02336480  150 mg All lots October 30, 2019
Ranbaxy Pharmaceuticals Canada Inc. Ran-Ranitidine 02336502  300 mg All lots October 30, 2019
Sandoz Canada Sandoz Ranitidine 02243229  150 mg All lots September 17, 2019
Sandoz Canada Sandoz Ranitidine 02243230  300 mg All lots September 17, 2019
Sanis Health Inc. Ranitidine 02353016  150 mg All lots September 25, 2019
Sanis Health Inc. Ranitidine 02353024  300 mg All lots September 25, 2019
Sanofi Consumer Health Inc. Zantac (ranitidine) 02230287  75 mg All lots October 18, 2019
Sanofi Consumer Health Inc. Zantac Maximum Strength Non-Prescription (ranitidine) 02277301  150 mg All lots October 18, 2019
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
 September 25, 2019
  • K46484
  • K46485
  • K48440
  • K48679
  • K50204
  • K50206
  • K50207
  • K50590
  • K50594
  • K50677
  • K50908
  • K50925
  • K50928
  • K50932
  • K50935
  • K51080
October 18, 2019
Sivem Pharmaceuticals ULC Ranitidine 02385961  300 mg
  • NP4177
  • NP4180
  • NT1365
  • PX8854
 September 25, 2019
  • K50624
  • K50941
  • K50947
  • K50950
October 18, 2019
Teva Canada Limited Act Ranitidine 02248570  150 mg All lots October 18, 2019
Teva Canada Limited Act Ranitidine 02248571  300 mg All lots October 18, 2019
Vita Health Products Inc. Acid Reducer (ranitidine) sold under the brand names Equate, iPharma, Stanley and Western Family 02298740  75 mg All lots October 25, 2019
Vita Health Products Inc. Maximum Strength Acid Reducer (ranitidine) sold under the brand names Equate, iPharma and Western Family 02298902  150 mg All lots October 25, 2019

Communications related to ranitidine recalls:

Nizatidine recalls

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

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

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

The following nizatidine products have been recalled in Canada.

Company Product Name/Active Pharmaceutical Ingredient (API) DIN Strength Lot Expiry
Pendopharm Division of Pharmascience Inc. AXID CAPS 100 00778338 150mg 616927 31-08-2020
617088 31-08-2020

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:

Very high blood sugars can also cause:

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

Contact your health care provider:

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.

List of metformin drugs being recalled in Canada
Company Product Name/Active Pharmaceutical Ingredient (API) DIN Strength Lot Expiry
Apotex Inc. APO-Metformin ER (Metformin Hydrochloride Extended-Release Tablets) 02305062 500 mg NV3242 04/2020
NV3244 04/2020
NV3245 04/2020
NV3243 04/2020
NV3247 04/2020
NV3248 04/2020
PX5334 01/2021
PX5335 01/2021
Ranbaxy Pharmaceuticals Canada Inc. RAN-Metformin 02269031 500 mg AJY8006A 05/2020
500 mg AJY8007A 05/2020
500 mg AJY8005A 05/2020
500 mg AJY8005B 05/2020
500 mg AJY8008A 05/2020
02269058 850 mg AJZ8005A 05/2020
JAMP Pharma Metformin 02380196 500 mg X20283 11/2020
X20284 11/2020
X20286 11/2020
X20287 11/2020
X20288 11/2020
Y00225 12/2020
Y00226 12/2020
Y00227 12/2020
Y00228 01/2021
Y00229 01/2021
Y00230 01/2021
Y00231 05/2021
Y00232 05/2021
Y01573 05/2021
Y01574 05/2021
Y01575 05/2021
Y01576 05/2021
Y01577 05/2021
Y01578 05/2021
Y01579 06/2021
Y01580 06/2021
02380218 850 mg X20385 07/2020
X20386 07/2020
X19224 10/2020
X19225 10/2020
X19226 10/2020
Apotex Inc APO-METFORMIN ER (Metformin Hydrochloride Extended-Release Tablets) 02305062 500mg PK3968 09/2020
PK3969 09/2020
PX5336 01/2021
PY7174 02/2021
PY7175 01/2021
RF6463 06/2021
RF6464 06/2021
RF6465 06/2021
RF6466 06/2021

Communications related to metformin recalls:

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