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Recalls, Market Withdrawals, & Safety Alerts

The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.

The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.

Date Brand Name(s) Product Description Product Type Recall Reason Description Company Name Terminated Recall Excerpt
Torrent Valsartan/Amlodipine/HCTZ Tablets Drugs, Prescription Drugs Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Torrent Pharmaceuticals Terminated … Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the … and for the treatment of heart failure. In combination with amlodipine plus hydrochlorothiazide, it is used to control … Description Lot/Batch Expiration Date NDC 13668-325-30 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP …
Torrent Pharmaceuticals Limited Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets Drugs, Generic Drugs Impurity Torrent Pharmaceuticals Limited Terminated … voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due … and for the treatment of heart failure. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it is …
Aurobindo, Acetris Valsartan and Amlodipine and Valsartan tablets Drugs, Prescription Drugs Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity AurobindoPharma USA, Inc. … a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due … a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due … any reports of adverse events related to this recall. Amlodipine Valsartan Tablets USP and Valsartan Tablets USP …
Prinston Pharmaceutical Inc. dba Solco Healthcare LLC Irbesartan and Irbesartan HCTZ Tablets Drugs, Prescription Drugs Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity Prinston Pharmaceutical Inc. dba Solco Healthcare LLC … treatment of heart failure. Irbesartan in combination with amlodipine plus hydrochlorothiazide is used to control high …
Aurobindo Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP Drugs, Generic Drugs Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Aurobindo Pharma USA, Inc. … USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, … any reports of adverse events related to this recall. Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, … for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, …
Mylan Valsartan-containing products Drugs, Prescription Drugs Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity Mylan Pharmaceuticals … within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the … NDC Name and Strength Size Lot No Expiry 0378-1721-93 Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 30 3064084 1/2019 0378-1721-93 Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of …
Teva Pharmaceuticals Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets Drugs Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Teva Pharmaceuticals … in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination … water, air pollution, and certain industrial processes. Amlodipine/Valsartan combination tablets and …
Mylan Amlodipine and Valsartan Tablets; Valsartan Tablets; Valsartan and Hydrochlorothiazide Tablets Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Mylan Pharmaceuticals … of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the … Description Strength Size Lot Number Expiry 0378-1721-93 Amlodipine and Valsartan Tablets, USP 5mg/160mg Bottles of 30 3066051 3/2019 0378-1722-93 Amlodipine and Valsartan Tablets, USP 10mg/160mg Bottles of …
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