Valsartan-containing products recalled by some manufacturers
 
Important recall notice
Valsartan-containing products recalled by some manufacturers

This page was last updated: 8/31/18

Note: Check back regularly for the most up-to-date information on this recall

On July 13th, the FDA announced a recall of medications containing Valsartan, a generic medication used to treat high blood pressure and heart failure from multiple manufacturers due to an impurity detected in the recalled products. The Food and Drug Administration has stated that because Valsartan is used to treat serious medical conditions, patients taking a recalled Valsartan-containing medication should continue taking their medicine until they have an alternative therapy or new supply.

FDA current findings on the impurity:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619024.htm?utm_campaign=Statement%20from%20FDA%20Commissioner%20Scott%20Gottlieb%2C%20M.D.%2C%20and%20Janet%20Woodcock%2C%20M.D.&utm_medium=email&utm_source=Eloqua

Where can I find the manufacturer name on my label?

The manufacturer information is located on the right-hand side and towards the bottom of the bottle label, as shown below.
Prescription bottle label example

Which Valsartan containing products are affected by the recall?

  • Valsartan with Hydrochlorothiazide manufactured by Alembic is NOT affected by this recall.
  • Solco is the only manufacturer currently providing customer reimbursement. If the manufacture on your label is not Solco, we recommend that you check this page periodically in the event that other manufacturers announce the availability of customer reimbursement in the future.
  • Additional information about the recall is available on the FDA website:

  • General Information: https://www.fda.gov/drugs/drugsafety/ucm613916.htm
    Non-Recalled Products: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615704.pdf
    Recalled Products:https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf
    • Solco Healthcare recall information - https://www.fda.gov/Safety/Recalls/ucm613504.htm
      For questions about returns/reimbursement, please contact Solco's consumer line at 888-679-5120. Solco customer service will require the NDC number of the product dispensed and a pharmacy receipt with the date of purchase. The NDC number can be located on the first page of your original invoice, next to the Rx number. Solco NDC numbers impacted by the recall are also listed below:

    • Drug Strength NDC number
      VALSARTAN TABS 160MG 43547036909
      VALSARTAN TABS 320MG 43547037009
      VALSARTAN TABS 40MG 43547036703
      VALSARTAN TABS 80MG 43547036809
      VALSARTAN/HCTZ TABS 80/12.5 43547031109
      VALSARTAN/HCTZ TABS 160/12H 43547031209
      VALSARTAN/HCTZ TABS 160/25 43547031309
      VALSARTAN/HCTZ TABS 320/25 43547031509
      VALSARTAN/HCTZ TABS 320/12H 43547031409

    • Major Pharmaceuticals recall information - https://www.fda.gov/Safety/Recalls/ucm613625.htm
    • Teva (Actavis/AvKARE/Watson) Pharmaceuticals recall information - https://www.fda.gov/Safety/Recalls/ucm613729.htm
    • Camber Pharmaceuticals recall information - https://www.fda.gov/Safety/Recalls/ucm616405.htm
      It is important to note that your home delivery pharmacy will NOT be accepting returns or providing credit for this recalled product. To request a return kit for your recalled product, please contact Qualanex (the recall coordinator for Camber) by email recall@qualanex.com or by calling 800-505-9291 toll free and follow the instructions below:
      1. Explain that your pharmacy is not accepting returns of the recalled product
      2. Provide the product NDC number (located on the first page of your original invoice, next to the Rx number) or a description of the tablet.
      3. You will be sent a return kit that includes a letter response form for you to complete and mail back in (allow two weeks for the return kit to arrive after requested).
    • Torrent Pharmaceuticals recall information - https://www.fda.gov/Safety/Recalls/ucm617821.htm
      All batches/lots of Valsartan containing products manufactured by Torrent Pharmaceuticals (Valsartan Tablets, Amlodipine/Valsartan Tablets and Amlodipine/Valsartan/HCTZ Tablets) are impacted by the recall. It is important to note that your home delivery pharmacy will NOT be accepting returns or providing credit for this recalled product. For questions regarding the return of recalled medication, please contact Qualanex (the recall coordinator for Torrent) at 1-800-505-9291 (live calls received 8am to 5:30 pm Eastern Time)

What do I need to know?

  • Because multiple manufacturers are impacted by this recall, there is limited supply of Valsartan containing products in the market place, specifically single ingredient Valsartan drug products. If you are taking single-ingredient Valsartan, it is very important that you speak with your prescriber about an alternative therapy and send in a new prescription for that new drug therapy. Refilling your existing prescription may result in a delay in processing and receipt of a different medication than originally prescribed.
  • The Food and Drug Administration has stated that patients who have the recalled medicine should continue taking it until they have a new supply unless otherwise directed by their healthcare provider. You should NOT discontinue taking your medication without direct guidance from your doctor.

Why was this medication recalled?

  • This voluntary recall is being issued by the manufacturers working with the FDA because an impurity, N-nitrosodimethylamine (NDMA), was detected in the recalled products. However, not all products containing Valsartan are being recalled.
  • Any suspected adverse events that may be related to the use of these products should be reported to your doctor. You can also report adverse events that may be related to this recall to FDA's Med Watch Program either online, by regular mail or by fax.

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The information on this site is not intended to take the place of your doctor or other healthcare professionals. It is a resource to help you make the best decisions and get the most from the medical services available to you. A licensed physician should be consulted for diagnosis and treatment of all medical conditions.