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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Valsartan and HCTZ Tablets Recalled for Carcinogen Impurity

Agency Publication Date: July 24, 2018
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Summary

Teva Pharmaceuticals USA is recalling approximately 648,222 bottles of Valsartan and Valsartan with Hydrochlorothiazide (HCTZ) tablets, used to treat high blood pressure. These medications were recalled because an impurity classified as a probable human carcinogen was found in the active ingredient used to make the tablets. No injuries or specific illnesses have been reported to date, but the medication was distributed nationwide throughout the United States, Puerto Rico, and Hawaii.

Risk

The drug contains an impurity that is considered a probable human carcinogen, meaning long-term exposure could potentially increase the risk of cancer. Because these medications are used for chronic conditions like high blood pressure, patients should not stop taking them without an immediate alternative treatment.

What You Should Do

  1. Check your prescription bottle for the product name (Valsartan or Valsartan/HCTZ), the dosage (40mg, 80mg, 160mg, or 320mg), and the NDC number (e.g., 0591-2315-19) to see if it matches the recalled list.
  2. Identify your lot number on the side of the bottle. Affected lots include 1191191M, 1191160M, 1191164M, 1191185M, 1191188M, 1196936A, 1175947M, 1177880A, 1208002A, and several others listed in the product details.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment; it is often riskier to stop taking blood pressure medication abruptly than to continue until a replacement is provided.
  4. Return any unused, affected medication to your pharmacy for a refund and further guidance on obtaining a safe replacement.
  5. Contact Teva Pharmaceuticals or the distributor, Actavis Pharma, Inc., if you have questions regarding the return process.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Patients should contact their healthcare provider or pharmacist. Unused product from affected lots should be returned to the place of purchase.

Affected Products

Product: Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg (90-count bottle)
Model:
NDC 0591-2315-19
Lot Numbers:
1191191M
1191192M
1191193M
1191194M
1191195M
1238466M
1238467M
1253261M
1256125M
1277709M
Product: Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg (90-count bottle)
Model:
NDC 0591-2316-19
Lot Numbers:
1191160M
1191161M
1191162A
1219363M
1219364M
1219365A
1225613A
1233944M
1233945M
1253253M
1253254M
Product: Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg (90-count bottle)
Model:
NDC 0591-2317-19
Lot Numbers:
1191164M
1191165M
1191166M
1191167A
1225612M
1250717M
1256111M
1288798M
Product: Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg (90-count bottle)
Model:
NDC 0591-2318-19
Lot Numbers:
1191185M
1191186M
1225615M
1233948M
1250718M
1253257M
Product: Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg (90-count bottle)
Model:
NDC 0591-2318-19
Lot Numbers:
1191188M
1191189M
1191190M
1199220M
1217576M
1217577M
1217578M
1220832M
1220833M
1247283M
1247284M
1247285M
1247286M
1247287A
1280632M
1280633M
Product: Valsartan Tablets, USP 40 mg (30-count and 90-count bottles)
Model:
NDC 0591-2167-30
NDC 0591-2167-19
Lot Numbers:
1196936A
1238463A
1270617A
1196934M
1238462M
1268429A
Product: Valsartan Tablets, USP 80 mg (90-count and 1000-count bottles)
Model:
NDC 0591-2168-19
NDC 0591-2168-10
Lot Numbers:
1175947M
1175948M
1177115A
1219361A
1240434M
1250704M
1177114A
1219360M
1250706A
Product: Valsartan Tablets, USP 160 mg (90-count and 1000-count bottles)
Model:
NDC 0591-2169-19
NDC 0591-2169-10
Lot Numbers:
1177880A
1220831A
1263941A
1175922M
1220826M
1236294M
1240427M
1270616A
Product: Valsartan Tablets, USP 320 mg (90-count and 500-count bottles)
Model:
NDC 0591-2170-19
NDC 0591-2170-05
Lot Numbers:
1208002A
1247282M
1263944M
1208000M
1208001M
1240425A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80538
Status: Active
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies; Healthcare providers
Manufactured In: Malta, India, United States
Units Affected: 9 products (56,603 bottles; 195,234 bottles; 99,554 bottles; 64,168 bottles; 164,922 bottles; 8,046 30-count bottles, 20,841 90-count bottles; 30,793 90-count bottles, 1,158 1000-count bottles; 15,347 90-count bottles, 8,378 1000-count bottles; 13,555 90-count bottles; 2,892 500-count bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.