Safety

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Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

For Immediate Release

July 17, 2018

Contact

Consumers

Teva’s Medical Information
druginfo@tevapharm.com
888-838-2872

Announcement

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution,  and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

To date, TEVA has not received any reports of adverse events related to this recall.

Valsartan is used for the treatment of hypertension (high blood pressure) and for the treatment of heart failure. It is also indicated as a treatment for left ventricular failure and left ventricular dysfunction following myocardial infarction. In combination with hydrochlorothiazide, it is used in the treatment of hypertension.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

The products subject to recall and listed below are packed in bottles. These lots were distributed Nationwide to Teva’s Direct Accounts (Wholesale/Distributor/Retail/Repackagers/VA Pharmacy, et. al).

NDCProduct Description/Strength/Bottle SizeLotExpiration
0591-2167-19Valsartan 40MG Tablets, USP 90 Count1196934MSep-2018
0591-2167-19Valsartan 40MG Tablets, USP 90 Count1238462MMay-2019
0591-2167-19Valsartan 40MG Tablets, USP 90 Count1268429AOct-2019
0591-2167-30Valsartan 40MG Tablets, USP 30 Count1196936ASep-2018
0591-2167-30Valsartan 40MG Tablets, USP 30 Count1238463AMay-2019
0591-2167-30Valsartan 40MG Tablets, USP 30 Count1270617AOct-2019
0591-2168-10Valsartan 80MG Tablets, USP 1000 Count1177114AJul-2018
0591-2168-10Valsartan 80MG Tablets, USP 1000 Count1219360MFeb-2019
0591-2168-10Valsartan 80MG Tablets, USP 1000 Count1250706AMay-2019
0591-2168-19Valsartan 80MG Tablets, USP 90 Count1175947MJul-2018
0591-2168-19Valsartan 80MG Tablets, USP 90 Count1175948MJul-2018
0591-2168-19Valsartan 80MG Tablets, USP 90 Count1177115AJul-2018
0591-2168-19Valsartan 80MG Tablets, USP 90 Count1219361AFeb-2019
0591-2168-19Valsartan 80MG Tablets, USP 90 Count1240434MMay-2019
0591-2168-19Valsartan 80MG Tablets, USP 90 Count1250704MMay-2019
0591-2169-10Valsartan 160MG Tablets, USP 1000 Count1175922MJul-2018
0591-2169-10Valsartan 160MG Tablets, USP 1000 Count1220826MFeb-2019
0591-2169-10Valsartan 160MG Tablets, USP 1000 Count1236294MMay-2019
0591-2169-10Valsartan 160MG Tablets, USP 1000 Count1240427MMay-2019
0591-2169-10Valsartan 160MG Tablets, USP 1000 Count1270616AAug-2019
0591-2169-19Valsartan 160MG Tablets, USP 90 Count1177880AJul-2018
0591-2169-19Valsartan 160MG Tablets, USP 90 Count1220831AFeb-2019
0591-2169-19Valsartan 160MG Tablets, USP 90 Count1263941AAug-2019
0591-2170-05Valsartan 320MG Tablets, USP 500 Count1208000MOct-2018
0591-2170-05Valsartan 320MG Tablets, USP 500 Count1208001MOct-2018
0591-2170-05Valsartan 320MG Tablets, USP 500 Count1240425AJun-2019
0591-2170-19Valsartan 320MG Tablets, USP 90 Count1208002AOct-2018
0591-2170-19Valsartan 320MG Tablets, USP 90 Count1247282MMay-2019
0591-2170-19Valsartan 320MG Tablets, USP 90 Count1263944MAug-2019
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1191191MAug-2018
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1191192MAug-2018
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1191193MAug-2018
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1191194MAug-2018
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1191195MAug-2018
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1238466MJun-2019
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1238467MJun-2019
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1253261MJul-2019
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1256125MJul-2019
0591-2315-19Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count1277709MSep-2019
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1191160MSep-2018
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1191161MSep-2018
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1191162ASep-2018
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1219363MFeb-2019
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1219364MFeb-2019
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1219365AFeb-2019
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1225613AFeb-2019
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1233944MApr-2019
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1233945MApr-2019
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1253253MJul-2019
0591-2316-19Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count1253254MJul-2019
0591-2317-19Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count1191164MSep-2018
0591-2317-19Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count1191165MSep-2018
0591-2317-19Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count1191166MSep-2018
0591-2317-19Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count1191167AOct-2018
0591-2317-19Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count1225612MFeb-2019
0591-2317-19Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count1250717MJul-2019
0591-2317-19Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count1256111MJul-2019
0591-2317-19Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count1288798MOct-2019
0591-2318-19Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count1191185MSep-2018
0591-2318-19Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count1191186MSep-2018
0591-2318-19Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count1225615MFeb-2019
0591-2318-19Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count1233948MFeb-2019
0591-2318-19Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count1250718MAug-2019
0591-2318-19Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count1253257MJul-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1191188MSep-2018
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1191189MSep-2018
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1191190MSep-2018
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1199220MAug-2018
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1217576MJan-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1217577MJan-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1217578MJan-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1220832MJan-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1220833MFeb-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1247283MJun-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1247284MJun-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1247285MJun-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1247286MJun-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1247287AJun-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1280632MOct-2019
0591-2319-19Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count1280633MOct-2019

Teva is notifying its Direct Accounts by FedEx Overnight mailing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts of this product recall and making arrangements for impacted product to be returned to Inmar. Instructions for returning recalled products and crediting are given in the recall letter.

Customers and patients with Medical-related Questions, information about an Adverse Event or other questions about the Teva product’s being recalled should contact Teva’s Medical Information by phone at: 888-838-2872, option 3, option 4, then option 1.

  • Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email druginfo@tevapharm.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to Teva directly at 888- 838-2872 or to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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

FDA Press Announcement

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Page Last Updated: 08/08/2018
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