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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):

CompanyProductNational Drug Code (NDC)LotExpiration
Teva Pharmaceuticals labeled as Major PharmaceuticalsValsartan 80 mg Tablets0904-6594-61T01795May-19
T01807May-19
T01712Feb-19
T01625Feb-19
T01596Feb-19
T01500Feb-19
T01466Jul-18
T01270Jul-18
Valsartan 160mg Tablets0904-6595-61T01646May-19
T01788May-19
T01668May-19
T01524Feb-19
T01269Jul-18
Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC.Valsartan 40mg Tablets, 30 count bottle 43547-367-03All lots07/2018 to 01/2020
Valsartan 80mg Tablets, 90 count bottle43547-368-09
Valsartan 160mg Tablets, 90 count bottle 43547-369-09
Valsartan 320mg Tablets, 90 count bottle43547-370-09
Valsartan and Hydrochlorothiazide (HCTZ) 80mg/12.5mg Tablets, 90 count bottle43547-311-09
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle43547-312-09
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/25mg Tablets, 90 count bottle43547-313-09
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle43547-314-09
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets, 90 count bottle43547-315-09
Teva Pharmaceuticals USA labeled as ActavisValsartan 40mg Tablets, 30 count bottle0591-2167-301196936ASep-18
1238463AMay-19
1270617AOct-19
Valsartan 40mg Tablets, 90 count bottle0591-2167-191196934MSep-18
1238462MMay-19
1268429AOct-19
Valsartan 80mg Tablets, 90 count bottle0591-2168-191175947MJul-18
1175948MJul-18
1177115AJul-18
1219361AFeb-19
1240434MMay-19
1250704MMay-19
Valsartan 80mg Tablets, 1000 count bottle0591-2168-101177114AJul-18
1219360MFeb-19
1250706AMay-19
Valsartan 160mg Tablets, 90 count bottle0591-2169-191177880AJul-18
1220831AFeb-19
1263941AAug-19
Valsartan 160mg Tablets, 1000 count bottle0591-2169-101175922MJul-18
1220826MFeb-19
1236294MMay-19
1240427MMay-19
1270616AAug-19
Valsartan 320mg Tablets, 90 count bottle0591-2170-191208002AOct-18
1247282MMay-19
1263944MAug-19
Valsartan 320mg Tablets, 500 count bottle0591-2170-051208000MOct-18
1208001MOct-18
1240425AJun-19
Valsartan and Hydrochlorothiazide (HCTZ) 80mg/12.5mg Tablets, 90 count bottle0591-2315-191191191MAug-18
1191192MAug-18
1191193MAug-18
1191194MAug-18
1191195MAug-18
1238466MJun-19
1238467MJun-19
1253261MJul-19
1256125MJul-19
1277709MSep-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle0591-2316-191191160MSep-18
1191161MSep-18
1191162ASep-18
1219363MFeb-19
1219364MFeb-19
1219365AFeb-19
1225613AFeb-19
1233944MApr-19
1233945MApr-19
1253253MJul-19
1253254MJul-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/25mg Tablets, 90 count bottle0591-2317-191191164MSep-18
1191165MSep-18
1191166MSep-18
1191167AOct-18
1225612MFeb-19
1250717MJul-19
1256111MJul-19
1288798MOct-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle0591-2318-191191185MSep-18
1191186MSep-18
1225615MFeb-19
1233948MFeb-19
1250718MAug-19
1253257MJul-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets, 90 count bottle0591-2319-191191188MSep-18
1191189MSep-18
1191190MSep-18
1199220MAug-18
1217576MJan-19
1217577MJan-19
1217578MJan-19
1220832MJan-19
1220833MFeb-19
1247283MJun-19
1247284MJun-19
1247285MJun-19
1247286MJun-19
1247287AJun-19
1280632MOct-19
1280633MOct-19
AvKAREValsartan and Hydrochlorthiazide (HCTZ) 80mg/12.5mg Tablet, 90 count bottle42291-884-9017349Aug-18
18395Aug-18
19221Jun-19
20029Jun-19
20158Jul-19
20843Jul-19
21411Sep-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablet, 90 count bottle42291-885-9017325Sep-18
17856Sep-18
18396Sep-18
18702Feb-19
19020Feb-19
19222Feb-19
20030Apr-19
20381Apr-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle42291-886-9017780Sep-18
18029Sep-18
18398Sep-18
18723Sep-18
19017Feb-19
19224Feb-19
20032Aug-19
20289Aug-19
21076Aug-19
21382Aug-19
Valsartan and Hydrochlorothizaide (HCTZ) 160mg/25mg Tablet, 90 count bottle42291-887-9017307Sep-18
17857Sep-18
18397Sep-18
18722Sep-18
19016Oct-18
19223Feb-19
20031Jul-19
20382Jul-19
21281Jul-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablet, 90 count bottle42291-888-9017308Sep-18
18158Sep-18
18539Jan-19
19021Jan-19
19225Jan-19
20033Jun-19
20290Jun-19
20565Jun-19
21369Oct-19
Remedy RepackValsartan and Hydrochlorothiazide 320mg/12.5mg tablet70518-0925-00B0383153-122917Dec-18
Valsartan and Hydrochlorothiazide 160mg/12.5mg tablet70518-0607-00B0318652-070617Jul-18
A-S Medication Solutions LLCValsartan 80mg Tablets54569-6582-1342B17019Sep-19
342B17018Aug-19
342B17004Feb-19
342B17002Nov-18
54569-6582-0342B17003Nov-18
342B17004Feb-19
Valsartan 160mg Tablets54569-6583-1343B17056Aug-19
343B17053Aug-19
343B17024Mar-19
343B17016Feb-19
54569-6583-0343B17019Feb-19
343B17023Mar-19
343B17056Aug-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets54569-6480-01233944MApr-19
1253253MJul-19
54569-6480-11253253MJul-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets54569-6488-01191188MSep-18
1191189MSep-18
1217576MJan-19
1247283MJun-19
1247285MJun-19
Bryant Ranch Prepack IncValsartan 80 mg Tablets, 28 count bottle63629-6922-4111158Feb-19
Valsartan 80mg Tablets, 60 count bottle63629-6922-3111158Feb-19
Valsartan 80mg Tablets, 90 count bottle63629-6922-2111158Feb-19
Valsartan 320 mg Tablets, 28 count bottle63629-6905-3114319Oct-18
109004Dec-18
Valsartan 320mg Tablets, 30 count bottle63629-6905-1114319Oct-18
109004Dec-18
Valsartan 320mg Tablets, 90 count bottle63629-6905-2114319Oct-18
109004Dec-18
Valsartan 320mg Tablets, 90 count bottle71335-0567-2120879Oct-19
H J Harkins Company Inc. dba Pharma PacValsartan 160mg Tablets, 90 count bottle76519-1158-9VSA000OVFeb-19
Proficient Rx LPValsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle71205-004-90All lots09/2018 to 07/2019
Northwind PharmaceuticalsValsartan 80mg Tablets, 30 count bottle51655-652-52UT48310002Oct-18
Valsartan 160mg Tablets51655-460-52UT48320002Jul-18
UT48320003May-19
Valsartan 320mg Tablets, 30 count bottle51655-654-52UT48100001Sep-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets51655-950-52UTB23790003Feb-19
Camber Pharmaceuticals, Inc.Valsartan 40mg Tablets, 30 count bottle31722-745-30All lots07/2018 – 06/2020
Valsartan 80mg Tablets, 90 count bottle31722-746-90All lots07/2018 – 06/2020
Valsartan 160mg Tablets, 90 count bottle31722-747-90All lots07/2018 – 06/2020
Valsartan 320mg Tablets, 90 count bottle31722-748-90All lots07/2018 – 06/2020
NuCare Pharmaceuticals IncValsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle68071-4311-9U01779Apr-19
Valsartan and Hydrochlorothiazide (HCTZ) 160mg/25mg Tablets, 30 count bottle68071-2119-3T11443Feb-19
Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets, 30 count bottle68071-4183-3T11577Jun-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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