VALSARTAN RECALL LIST - FDA
FDA Valsartan & Losartan Recall List Updates:
TEVA Losartan Recall Expanded Losartan Potassium to 50 mg and 100 mg Tablets USP by Teva Pharmaceuticals USA: Expanded Recall - Due to the Detection of an Impurity – N-Nitroso-N-methyl-4-aminobutyric acid - June 12, 2019
FDA annouces the voluntary recall of Vivimed Life Sciences Pvt Ltd's Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity
See: Vivimed Life Sciences Valsartan Recall May 6, 2019
FDA Approves new generic Valsartan
The U.S. Food and Drug Administration approved a new generic of Diovan (valsartan) to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities - March 12, 2019 -
https://www.fda.gov/Safety/Recalls/ucm629693.htm Jan. 23, 2019
Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.
https://www.fda.gov/Safety/Recalls/ucm629261.htm Jan. 3, 2019
Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
https://www.fda.gov/Safety/Recalls/ucm628966.htm December 20, 2018
Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
https://www.fda.gov/Safety/Recalls/ucm627647.htm Dec. 4, 2018
Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
https://www.fda.gov/Safety/Recalls/ucm626802.htm Nov. 27, 2018
Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry
https://www.fda.gov/Safety/Recalls/ucm626367.htm Nov. 20, 2018
Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
https://www.fda.gov/Safety/Recalls/ucm624593.htm Oct. 30, 2018
Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)
https://www.fda.gov/Safety/Recalls/ucm624547.htm Oct 26, 2018
Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)
https://www.fda.gov/Safety/Recalls/ucm617821.htm Aug 23, 2018
UPDATED:ADDITIONAL LOTS ADDED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets
https://www.fda.gov/Safety/Recalls/ucm617347.htm Aug 17, 2018
Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets
https://www.fda.gov/Safety/Recalls/ucm616405.htm Aug 8, 2018
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)
https://www.fda.gov/Safety/Recalls/ucm613729.htm July 17, 2018
Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets
https://www.fda.gov/Safety/Recalls/ucm613504.htm July 17, 2018
Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products
https://www.fda.gov/Safety/Recalls/ucm613625.htm July13, 2018
Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)
