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Dangerous Drug Recall Attorneys Representing Injured Victims Nationwide

The U.S. Food and Drug Administration (FDA) announced the first voluntary recall of certain products containing valsartan on July 13, 2018, due to the discovery of an impurity in the drugs. The impurity, N-nitrosodimethylamine or NDMA, is a probable human carcinogen, which means that it poses a potential cancer risk to those taking the drug.

Not all drugs containing valsartan are under a recall. The recalled hypertension drugs, thus far, contain valsartan medicine manufactured by Zhejiang Huahai Pharmaceuticals (Linhai, China) or Hetero Labs Limited (India). The FDA investigation is ongoing and the list of recalled valsartan-containing products is continuously updated. To see a full list of recalled valsartan products, see the chart below on this page or view the full list on the FDA’s website.

If you have been diagnosed with any of the following after taking a recalled valsartan drug, contact Thomas J. Henry immediately to discuss your case with an attorney:

  • Liver damage, including liver fibrosis and scarring of the liver
  • Tumors of the liver
  • Liver cancer

Our pharmaceutical drug attorneys will provide you with a free legal consultation. Fill out the contact form on this page or call 888-314-9945 to speak with a lawyer today.

List of Recalled Valsartan-containing Products

The following products are included in the FDA recall (updated by FDA, as of August 8, 2018):

Company Product National Drug Code (NDC) Lot Expiration
Teva Pharmaceuticals labeled as Major Pharmaceuticals Valsartan 80 mg Tablets 0904-6594-61 T01795 May-19
T01807 May-19
T01712 Feb-19
T01625 Feb-19
T01596 Feb-19
T01500 Feb-19
T01466 Jul-18
T01270 Jul-18
Valsartan 160mg Tablets 0904-6595-61 T01646 May-19
T01788 May-19
T01668 May-19
T01524 Feb-19
T01269 Jul-18
Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC. Valsartan 40mg Tablets, 30 count bottle  43547-367-03 All lots 07/2018 to 01/2020
Valsartan 80mg Tablets, 90 count bottle 43547-368-09
Valsartan 160mg Tablets, 90 count bottle  43547-369-09
Valsartan 320mg Tablets, 90 count bottle 43547-370-09
Valsartan and Hydrochlorothiazide (HCTZ) 80mg/12.5mg Tablets, 90 count bottle 43547-311-09
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle 43547-312-09
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/25mg Tablets, 90 count bottle 43547-313-09
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle 43547-314-09
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets, 90 count bottle 43547-315-09
Teva Pharmaceuticals USA labeled as Actavis Valsartan 40mg Tablets, 30 count bottle 0591-2167-30 1196936A Sep-18
1238463A May-19
1270617A Oct-19
Valsartan 40mg Tablets, 90 count bottle 0591-2167-19 1196934M Sep-18
1238462M May-19
1268429A Oct-19
Valsartan 80mg Tablets, 90 count bottle 0591-2168-19 1175947M Jul-18
1175948M Jul-18
1177115A Jul-18
1219361A Feb-19
1240434M May-19
1250704M May-19
Valsartan 80mg Tablets, 1000 count bottle 0591-2168-10 1177114A Jul-18
1219360M Feb-19
1250706A May-19
Valsartan 160mg Tablets, 90 count bottle 0591-2169-19 1177880A Jul-18
1220831A Feb-19
1263941A Aug-19
Valsartan 160mg Tablets, 1000 count bottle 0591-2169-10 1175922M Jul-18
1220826M Feb-19
1236294M May-19
1240427M May-19
1270616A Aug-19
Valsartan 320mg Tablets, 90 count bottle 0591-2170-19 1208002A Oct-18
1247282M May-19
1263944M Aug-19
Valsartan 320mg Tablets, 500 count bottle 0591-2170-05 1208000M Oct-18
1208001M Oct-18
1240425A Jun-19
Valsartan and Hydrochlorothiazide (HCTZ) 80mg/12.5mg Tablets, 90 count bottle 0591-2315-19 1191191M Aug-18
1191192M Aug-18
1191193M Aug-18
1191194M Aug-18
1191195M Aug-18
1238466M Jun-19
1238467M Jun-19
1253261M Jul-19
1256125M Jul-19
1277709M Sep-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle 0591-2316-19 1191160M Sep-18
1191161M Sep-18
1191162A Sep-18
1219363M Feb-19
1219364M Feb-19
1219365A Feb-19
1225613A Feb-19
1233944M Apr-19
1233945M Apr-19
1253253M Jul-19
1253254M Jul-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/25mg Tablets, 90 count bottle 0591-2317-19 1191164M Sep-18
1191165M Sep-18
1191166M Sep-18
1191167A Oct-18
1225612M Feb-19
1250717M Jul-19
1256111M Jul-19
1288798M Oct-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle 0591-2318-19 1191185M Sep-18
1191186M Sep-18
1225615M Feb-19
1233948M Feb-19
1250718M Aug-19
1253257M Jul-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets, 90 count bottle 0591-2319-19 1191188M Sep-18
1191189M Sep-18
1191190M Sep-18
1199220M Aug-18
1217576M Jan-19
1217577M Jan-19
1217578M Jan-19
1220832M Jan-19
1220833M Feb-19
1247283M Jun-19
1247284M Jun-19
1247285M Jun-19
1247286M Jun-19
1247287A Jun-19
1280632M Oct-19
1280633M Oct-19
AvKARE Valsartan and Hydrochlorthiazide (HCTZ) 80mg/12.5mg Tablet, 90 count bottle 42291-884-90 17349 Aug-18
18395 Aug-18
19221 Jun-19
20029 Jun-19
20158 Jul-19
20843 Jul-19
21411 Sep-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablet, 90 count bottle 42291-885-90 17325 Sep-18
17856 Sep-18
18396 Sep-18
18702 Feb-19
19020 Feb-19
19222 Feb-19
20030 Apr-19
20381 Apr-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle 42291-886-90 17780 Sep-18
18029 Sep-18
18398 Sep-18
18723 Sep-18
19017 Feb-19
19224 Feb-19
20032 Aug-19
20289 Aug-19
21076 Aug-19
21382 Aug-19
Valsartan and Hydrochlorothizaide (HCTZ) 160mg/25mg Tablet, 90 count bottle 42291-887-90 17307 Sep-18
17857 Sep-18
18397 Sep-18
18722 Sep-18
19016 Oct-18
19223 Feb-19
20031 Jul-19
20382 Jul-19
21281 Jul-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablet, 90 count bottle 42291-888-90 17308 Sep-18
18158 Sep-18
18539 Jan-19
19021 Jan-19
19225 Jan-19
20033 Jun-19
20290 Jun-19
20565 Jun-19
21369 Oct-19
Remedy Repack Valsartan and Hydrochlorothiazide 320mg/12.5mg tablet 70518-0925-00 B0383153-122917 Dec-18
Valsartan and Hydrochlorothiazide 160mg/12.5mg tablet 70518-0607-00 B0318652-070617 Jul-18
A-S Medication Solutions LLC Valsartan 80mg Tablets 54569-6582-1 342B17019 Sep-19
342B17018 Aug-19
342B17004 Feb-19
342B17002 Nov-18
54569-6582-0 342B17003 Nov-18
342B17004 Feb-19
Valsartan 160mg Tablets 54569-6583-1 343B17056 Aug-19
343B17053 Aug-19
343B17024 Mar-19
343B17016 Feb-19
54569-6583-0 343B17019 Feb-19
343B17023 Mar-19
343B17056 Aug-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets 54569-6480-0 1233944M Apr-19
1253253M Jul-19
54569-6480-1 1253253M Jul-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets 54569-6488-0 1191188M Sep-18
1191189M Sep-18
1217576M Jan-19
1247283M Jun-19
1247285M Jun-19
Bryant Ranch Prepack Inc Valsartan 80 mg Tablets, 28 count bottle 63629-6922-4 111158 Feb-19
Valsartan 80mg Tablets, 60 count bottle 63629-6922-3 111158 Feb-19
Valsartan 80mg Tablets, 90 count bottle 63629-6922-2 111158 Feb-19
Valsartan 320 mg Tablets, 28 count bottle 63629-6905-3 114319 Oct-18
109004 Dec-18
Valsartan 320mg Tablets, 30 count bottle 63629-6905-1 114319 Oct-18
109004 Dec-18
Valsartan 320mg Tablets, 90 count bottle 63629-6905-2 114319 Oct-18
109004 Dec-18
Valsartan 320mg Tablets, 90 count bottle 71335-0567-2 120879 Oct-19
H J Harkins Company Inc. dba Pharma Pac Valsartan 160mg Tablets, 90 count bottle 76519-1158-9 VSA000OV Feb-19
Proficient Rx LP Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle 71205-004-90 All lots 09/2018 to 07/2019
Northwind Pharmaceuticals Valsartan 80mg Tablets, 30 count bottle 51655-652-52 UT48310002 Oct-18
Valsartan 160mg Tablets 51655-460-52 UT48320002 Jul-18
UT48320003 May-19
Valsartan 320mg Tablets, 30 count bottle 51655-654-52 UT48100001 Sep-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets 51655-950-52 UTB23790003 Feb-19
Camber Pharmaceuticals, Inc. Valsartan 40mg Tablets, 30 count bottle 31722-745-30 All lots 07/2018 – 06/2020
Valsartan 80mg Tablets, 90 count bottle 31722-746-90 All lots 07/2018 – 06/2020
Valsartan 160mg Tablets, 90 count bottle 31722-747-90 All lots 07/2018 – 06/2020
Valsartan 320mg Tablets, 90 count bottle 31722-748-90 All lots 07/2018 – 06/2020
NuCare Pharmaceuticals Inc Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle 68071-4311-9 U01779 Apr-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/25mg Tablets, 30 count bottle 68071-2119-3 T11443 Feb-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets, 30 count bottle 68071-4183-3 T11577 Jun-19

(Source: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf)

Valsartan-containing drugs that are not affected by the recall can be found here.

Valsartan Recall Timeline

  • July 13, 2018 – FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity
  • July 18, 2018 – FDA updates health care professionals and patients on recent valsartan recalls
    • Includes list of drugs affected by recall
  • July 24, 2018 – FDA publishes a list of valsartan-containing products not part of the recall
  • July 27, 2018 – FDA updates list of recalled valsartan-containing products; FDA releases analysis of NDMA levels in recalled valsartan in the U.S.
    • The amounts of NDMA found in the recalled batches of valsartan exceeded acceptable levels
    • Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years
  • August 2, 2018 – FDA updates list of recalled valsartan-containing products and products not part of the recall; FDA reminds manufacturers to evaluate processes for unsafe impurities
  • August 9, 2018 – FDA updates list of recalled valsartan-containing products, including certain products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc.
    • FDA is investigating whether other types of angiotensin II receptor blockers (ARBs), like valsartan, are at risk for the presence of NDMA

For up-to-date information from the FDA regarding the valsartan recall, visit their website here.

What Should I Do if I’m Taking a Recalled Valsartan Drug?

The following information is provided by the FDA for patients currently taking valsartan drugs that are under recall:

  • Continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option.
  • Not all valsartan-containing medications are affected and being recalled.
  • If you are taking any medication containing valsartan, compare the information on your prescription bottle with the information in this list (company, National Drug Code, lot number) to determine if your current medicine has been recalled. If you are not certain, contact your pharmacist.
  • If you have medicine included in the recall, contact your pharmacist. The pharmacist may be able to provide you with valsartan made by another company. If not, contact your doctor immediately to discuss other treatment options.

The FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. Untreated heart failure increases the risk of hospitalization and death.

Contact an Experienced Dangerous Drug Attorney

If you have suffered from liver damage, the development of liver tumors, or liver cancer after taking valsartan drugs that are under recall, contact Thomas J. Henry today. Our personal injury law firm is nationally recognized with a track record of obtaining real results for our clients for more than 25 years. Let our experienced pharmaceutical drug lawyers help you determine if you have a claim. We are available 24/7, nights and weekends to take your call and provide you with a free legal consultation. Thomas J. Henry represents clients nationwide suffering from injuries caused by dangerous drugs.

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877-969-8159 • info@tjhlaw.com

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