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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Amlodipine and Valsartan Combination Tablets Recalled for Potential Carcinogen

Agency Publication Date: December 11, 2018
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Summary

Teva Pharmaceuticals has voluntarily recalled approximately 508,220 bottles of several blood pressure medications, including Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets. Laboratory testing confirmed that these products contain an impurity called N-nitrosodimethylamine (NDEA), which is a suspected human carcinogen. These medications are used to treat high blood pressure and were distributed nationwide in various dosage strengths in both 30-count and 90-count bottles.

Risk

The medications contain NDEA, an impurity that is classified as a probable human carcinogen and may cause cancer with long-term exposure. Patients are advised not to stop taking their medication without a replacement, as the risk of untreated high blood pressure can be immediate and severe.

What You Should Do

  1. Check your prescription bottle for the product name and NDC (National Drug Code) number to see if your medication is affected. Recalled products include Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide tablets in various strengths.
  2. Verify the lot number on your bottle against the affected list: Amlodipine/Valsartan 5mg/160mg (Lots 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024), 10mg/160mg (Lots 24X012, 24X013), 5mg/320mg (Lots 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037), and 10mg/320mg (Lots 26X036, 26X038, 26X039, 26X040, 26X041, 26X042, 26X043, 26X044, 26X045, 26X046, 26X047, 26X048, 26X049, 26X050, 26X051).
  3. Check triple-combination tablets (Amlodipine/Valsartan/HCTZ) for lots: 18X010, 18X011 (5/160/12.5mg); 20X006 (10/160/12.5mg); 21X006, 21X007 (10/160/25mg); and all unexpired lots of NDC 0093-7809-56/98 (10/320/25mg).
  4. Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking your medication.
  5. Return any unused portions of the recalled medication to your pharmacy to receive a refund and for proper disposal.
  6. Contact Teva Pharmaceuticals USA at 1-888-838-2872 or visit www.tevausa.com for more information regarding this recall.
  7. For further questions or to report adverse effects, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and alternative guidance

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

Affected Products

Product: Amlodipine and Valsartan Tablets 5 mg/160 mg (30-count and 90-count bottles)
Model:
NDC 0093-7690-56
NDC 0093-7690-98
Lot Numbers:
23X017
23X018
23X019
23X020
23X022
23X023
23X024
Product: Amlodipine and Valsartan Tablets 10 mg/160 mg (30-count and 90-count bottles)
Model:
NDC 0093-7961-56
NDC 0093-7691-98
Lot Numbers:
24X012
24X013
Product: Amlodipine and Valsartan Tablets 5 mg/320 mg (30-count and 90-count bottles)
Model:
NDC 0093-7692-56
NDC 0093-7692-98
Lot Numbers:
25X028
25X029
25X030
25X031
25X032
25X035
25X037
Product: Amlodipine and Valsartan Tablets 10 mg/320 mg (30-count and 90-count bottles)
Model:
NDC 0093-7693-56
NDC 0093-7693-98
Lot Numbers:
26X036
26X038
26X039
26X040
26X041
26X042
26X043
26X044
26X045
26X046
26X047
26X048
26X049
26X050
26X051
Product: Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg (30-count and 90-count bottles)
Model:
NDC 0093-7807-56
NDC 0093-7807-98
Lot Numbers:
18X010
18X011
Product: Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg (30-count and 90-count bottles)
Model:
NDC 0093-7810-56
NDC 0093-7810-98
Lot Numbers:
20X006
Product: Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg (30-count and 90-count bottles)
Model:
NDC 0093-7960-56
NDC 0093-7038-56
NDC 0093-7038-98
NDC 0093-7690-98
Lot Numbers:
21X006
21X007
Product: Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg (30-count and 90-count bottles)
Model:
NDC 0093-7809-56
NDC 0093-7809-98
Lot Numbers:
All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81646
Status: Active
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies nationwide
Manufactured In: Israel, United States
Units Affected: 8 products (120,394 bottles; 39,617 bottles; 75,883 bottles; 142,260 bottles; 41,572 bottles; 19,458 bottles; 37,957 bottles; 31,079 bottles)
Distributed To: Nationwide
Agency Last Updated: December 26, 2018

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.

Find an Attorney

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.