Mylan extends recall of blood-pressure products containing Valsartan

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Mylan N.V. has drastically expanded its recall of high-blood-pressure medications containing Valsartan because tests have found trace amounts of a possible cancer-causing chemical.

The latest recall adds 104 lots of drugs to those already recalled, including 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).

The recalls began after tests found trace amounts of an impurity, N-nitrosodiethylamine (NDEA), a substance tat occurs naturally in some foods, drinking waster, air pollution and industrial processes. It has been declared a “probable human carcinogen” by the  International Agency for Research on Cancer (IARC).

Just how NDEA found its way into the drug batches isn’t known. Since NDEA occurs naturally, it may be present in one or more of the ingredients used to formulate the drug, Or it may be a byproduct of the Valsartan manufacturing process, a practicing internist in the Washington, D.C., area suggested to Rx411. He asked not to be publicly identified.

Don’t stop suddenly


Physicians and public health officials are emphasizing that patients should not simply stop taking the recalled products. Rather, they should contact their physician, who can switch them to another medication.

The long-term risk of cancer is slight while the short-term danger of abruptly stopping Valsartan or any other blood-pressure medication is much higher.

Recalled batches

The recalled batches were distributed in the U.S. between March 2017 and November 2018.   The expanded recalled batches are as follows:

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 30 3069629 5/2019
0378-1721-93 Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 30 3073148 8/2019
0378-1721-93 Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 30 3073149 8/2019
0378-1721-93 Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 30 3076093 10/2019
0378-1721-93 Amlodipine and Valsartan Tablets, USP  5/160 mg Bottles of 30 3077772 11/2019
0378-1722-93 Amlodipine and Valsartan Tablets, USP 10/160 mg Bottles of 30 3064085 1/2019
0378-1722-93 Amlodipine and Valsartan Tablets, USP 10/160 mg Bottles of 30 3066063 3/2019
0378-1722-93 Amlodipine and Valsartan Tablets, USP 10/160 mg Bottles of 30 3069638 5/2019
0378-1722-93 Amlodipine and Valsartan Tablets, USP 10/160 mg Bottles of 30 3069639 6/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3064086 1/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3066061 3/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3066062 3/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3073145 9/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3073146 9/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3073147 9/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3076091 11/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3077619 11/2019
0378-1723-93 Amlodipine and Valsartan Tablets, USP 5/320 mg Bottles of 30 3082432 3/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10/320 mg Bottles of 30 3066064 3/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10/320 mg Bottles of 30 3069645 6/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10/320 mg Bottles of 30 3069646 6/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10/320 mg Bottles of 30 3073142 9/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10/320 mg Bottles of 30 3073143 9/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10/320 mg Bottles of 30 3073144 9/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10/320 mg Bottles of 30 3077617 11/2019
NDC Name and Strength Size Lot No Expiry
0378-5807-93 Valsartan Tablets, USP 40 mg Bottles of 30 3063780 1/2019
0378-5807-93 Valsartan Tablets, USP 40 mg Bottles of 30 3074879 10/2019
0378-5807-93 Valsartan Tablets, USP 40 mg Bottles of 30 3086684 6/2020
0378-5807-93 Valsartan Tablets, USP 40 mg Bottles of 30 3086687 6/2020
0378-5813-77 Valsartan Tablets, USP 80 mg Bottles of 90 3065445 2/2019
0378-5813-77 Valsartan Tablets, USP 80 mg Bottles of 90 3074880 10/2019
0378-5813-77 Valsartan Tablets, USP 80 mg Bottles of 90 3074883 10/2019
0378-5813-77 Valsartan Tablets, USP 80 mg Bottles of 90 3086688 6/2020
0378-5813-77 Valsartan Tablets, USP 80 mg Bottles of 90 3086689 6/2020
0378-5813-77 Valsartan Tablets, USP 80 mg Bottles of 90 3086710 6/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3069019 5/2019
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3069020 5/2019
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3069021 5/2019
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3069022 5/2019
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3071354 7/2019
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3071355 7/2019
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3071357 7/2019
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3079023 1/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3079027 1/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3079028 1/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3079029 1/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3079996 2/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3079997 2/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3079998 2/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3083635 4/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3086715 6/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3086716 7/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3086717 7/2020
0378-5814-77 Valsartan Tablets, USP 160 mg Bottles of 90 3088623 8/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3063783 1/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3063784 1/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3063785 1/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3064092 1/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3064093 1/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3064094 1/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3070349 6/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3070350 6/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3070351 6/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3070352 6/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3070353 6/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3070354 6/2019
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3079030 1/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3079031 1/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3079032 1/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3079033 1/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3080011 2/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3080224 2/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3081498 3/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3081500 3/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3087126 7/2020
0378-5815-77 Valsartan Tablets, USP 320 mg Bottles of 90 3088476 8/2020
NDC Name and Strength Size Lot No Expiry
0378-6321-77 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg Bottles of 90 3084363 2/2019
0378-6321-77 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg Bottles of 90 3084364 2/2019
0378-6321-77 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg Bottles of 90 3093800 12/2019
0378-6321-05 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg Bottles of 500 3084363 2/2019
0378-6321-05 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg Bottles of 500 3093800 12/2019
0378-6322-77 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg Bottles of 90 2008880 8/2020
0378-6322-77 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg Bottles of 90 3084358 2/2019
0378-6322-77 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg Bottles of 90 3084359 2/2019
0378-6322-77 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg Bottles of 90 3093801 12/2019
0378-6322-05 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg Bottles of 500 3084359 2/2019
0378-6322-05 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg Bottles of 500 3084361 2/2019
0378-6322-05 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg Bottles of 500 3093801 12/2019
0378-6323-77 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg Bottles of 90 3084887 2/2019
0378-6323-77 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg Bottles of 90 3093802 12/2019
0378-6323-05 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg Bottles of 500 3084887 2/2019
0378-6323-05 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg Bottles of 500 3084888 2/2019
0378-6323-05 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg Bottles of 500 3093802 12/2019
0378-6324-77 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg Bottles of 90 3084889 2/2019
0378-6324-77 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg Bottles of 90 3093803 12/2019
0378-6324-05 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg Bottles of 500 3084890 2/2019
0378-6324-05 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg Bottles of 500 3093803 12/2019
0378-6325-77 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg Bottles of 90 3084860 2/2019
0378-6325-77 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg Bottles of 90 3084861 2/2019
0378-6325-77 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg Bottles of 90 3084862 2/2019
0378-6325-77 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg Bottles of 90 3093804 12/2019
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg Bottles of 500 3084862 2/2019
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg Bottles of 500 3084863 2/2019

FDA wants feedback

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

  • Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About the Author

Truman Lewis
Truman has been a bureau chief and correspondent in D.C., Los Angeles, Phoenix and elsewhere, reporting for radio, television, print and news services, for more than 30 years. Most recently, he has reported extensively on health and consumer issues for ConsumerAffairs.com and FairfaxNews.com.