Since July 2018, there have been a string of recalls related to three common generic heart drugs — losartan, irbesartan and valsartan — due to the detection of probable human carcinogens.
A timeline of the recalls:
July 13, 2018. Major Pharmaceuticals becomes the first distribution firm to voluntarily recall valsartan. It included all lots of 80 mg tablets and 160 mg tablets supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals. The product was found to contain the probable human carcinogen n-nitrosodimethylamine, also known as NDMA.
July 16, 2018. Prinston Pharmaceuticals, which does business as Solco Healthcare, recalls several versions of its valsartan tablets, including 40 mg, 80 mg, 160 mg, and 320 mg lots. It also recalls its generic valsartan-hydrochlorothiazide tablets 80 mg/12.5mg, 160 mg/12.5 mg, 160 mg/25 mg, 320mg/12.5 mg, and 320 mg/25 mg. The drugs were found to contain NDMA.
July 17, 2018. Teva Pharmaceutical recalls 29 lots of single and 51 lots of combination valsartan medications distributed under the Actavis label due to the detection of trace amounts of NDMA.
Aug. 7, 2018. Camber Pharmaceuticals recalls all unexpired lots of valsartan tablets in 40 mg, 80 mg, 160 mg and 320 mg, at the hospital, retail and consumer level. The recall was prompted by the detection of NDMA.
Aug. 17, 2018. Torrent Pharmaceuticals recalls 14 lots of valsartan/amlodipine/HCTZ tablets due to the potentially carcinogenic NDMA impurity.
Aug. 22, 2018. Torrent Pharmaceuticals expands its recall of valsartan/amlodipine/HCTZ tablets to include all unexpired lots. The NDMA impurity remains the reason for recall.
Oct. 26, 2018. Between August and October, the FDA identified another potentially carcinogenic impurity found in generic blood pressure drugs irbesartan and losartan. Aurobindo Pharma becomes the first drugmaker to voluntarily recall irbesartan due to a different impurity known as N-nitrosodiethylamine, NDEA. The recall includes 22 batches of the drug, which was supplied to ScieGen Pharmaceuticals.
Nov. 8, 2018. Sandoz, the generic arm of Novartis, voluntarily recalls one lot of losartan potassium hydrochlorothiazide tablets at the consumer level. It was found to contain NDEA.
Nov. 20, 2018. Mylan Pharmaceuticals recalls six lots of amlodipine and valsartan tablets, several lots of valsartan tablets and two lots of valsartan and hydrochlorothiazide tablets at the consumer level. The tablets were found to contain NDEA.
Nov. 27, 2018. Teva Pharmaceuticals issues a voluntary recall of all lots of its amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets over the detection of NDEA.
Dec. 4, 2018. Mylan expands its voluntary nationwide recall to include all lots of any valsartan-containing products within expiry. This includes an additional 104 lots. The products were found to contain NDEA.
Dec. 20, 2018. Torrent Pharmaceuticals voluntarily recalls two lots of losartan potassium tablets due to the impurity NDEA.
Dec. 31, 2018. Aurobindo Pharma conducts a voluntary recall of 80 lots of its amlodipine valsartan tablets, valsartan HCTZ tablets USP, and valsartan tablets due to the detection of NDEA.
Jan. 3. Torrent Pharmaceuticals expands its Dec. 20 recall of losartan potassium tablets to a total of 10 lots due to trace amounts of NDEA.
Jan. 18. Prinston Pharmaceuticals, doing business as Solco Healthcare, initiates a voluntary recall of one lot of irbesartan and seven lots of irbesartan HCTZ tablets due to the detection of NDEA.
Jan. 22. Torrent Pharmaceuticals expands its recall of losartan potassium tablets again, due to the detection of NDEA. This time, Torrent includes six additional lots of losartan potassium hydrochlorothiazide tablets.
Feb. 22. Macleods Pharmaceuticals voluntarily recalls one lot of losartan potassium hydrochlorothiazide combination tablets due to the detection of the potentially carcinogenic impurity NDEA.
Feb. 28. Another potential carcinogen, N-Nitroso N-Methyl 4-amino butyric acid, NMBA, is detected in various generic heart drugs. Camber Pharmaceuticals becomes the first drugmaker to recall losartan tablets over the detection of the new potentially carcinogenic impurity. The drugmaker recalls 87 lots of losartan tablets at the consumer level.
March 1. Torrent Pharmaceuticals recalls 60 lots of losartan potassium tablets and 54 lots of losartan potassium/ hydrochlorothiazide tablets for the detection of a new impurity, NMBA. Aurobindo Pharma also issues a recall on March 3. It is a recall expansion of 38 lots of valsartan amlodipine and valsartan tablets for the detection of NDEA.
March 7. American Health Packaging recalls one lot of valsartan tablets due to the detection of NDEA. It is a result of the detection of NDEA in a product manufactured by Aurobindo Pharma repackaged by American Health Purchasing.
March 15. Legacy Pharmaceutical Packaging recalls three repackaged lots of losartan tablets due to Torrent Pharmaceutical issuing a nationwide recall of its losartan tablets over the detection of NMBA.
March 19. Legacy Pharmaceutical Packaging recalls an additional 40 repackaged lots of losartan due to Camber Pharmaceuticals' Feb. 28 recall of losartan with trace amounts of NMBA.
April 18. Torrent Pharmaceuticals expands its recall of losartan potassium tablets and losartan potassium hydrochlorothiazide tablets for the detection of NMBA. It includes an additional 36 lots of the drugs.
April 24. Legacy Pharmaceutical Packaging recalls one more lot of repackaged losartan tablets manufactured by Torrent. It is a result of Torrent's April 18 expanded recall over the detection of NMBA.
April 26. Teva Pharmaceuticals issues a nationwide recall of 35 lots of bulk losartan potassium tablets over the detection of NMBA. It was sold under the brand name GSMS Inc.
May 3. Vivimed Life Sciences recalls 19 lots of losartan potassium tablets due to the detection of NMBA. The product was made by Vivimed at its production plant in India, but the active ingredient was manufactured by Heritage Pharmaceuticals.