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Unrated Drug recall · FDA · Published August 14, 2018

Jubilant Cadista Valsartan Tablets Recall: Incorrect Excipient Risk

Jubilant Cadista recalls 320mg Valsartan tablets due to potential incorrect excipient used in manufacturing. Affected lots from Roorkee, India. No specific remedy stated in official notice.

🇺🇸 FDA recall #D-1106-2018DrugJubilant Cadista ›
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Recalling firmJubilant Cadista Pharmaceuticals, Inc.207 Kiley Dr · Salisbury, MD 21801-2249
✎ GovInfoNow plain-language explainer

What happened, in plain English

Jubilant Cadista has recalled 320mg Valsartan tablets that may contain an incorrect excipient. This could pose a health risk to patients taking the medication. The recall affects specific lots manufactured in India with certain expiration dates. Read more at govinfonow.com/recall/39727-jubilant-cadista-valsartan-tablets-recall-incorrect-excipient-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39727-jubilant-cadista-valsartan-tablets-recall-incorrect-excipient-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1106-2018

Cite this page

“Jubilant Cadista Valsartan Tablets Recall: Incorrect Excipient Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39727-jubilant-cadista-valsartan-tablets-recall-incorrect-excipient-risk. Based on FDA recall #D-1106-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1106-2018%22&limit=1).

Why it’s dangerous

The recall states there may be an incorrect grade of excipient used during manufacturing. This could lead to potential health risks for patients taking the medication. The exact nature of the risk is not specified in the official notice.

Who’s affected

Patients prescribed this medication by a doctor are affected. Those using the specific lots with the described manufacturing details are most at risk.

How to tell if you have this one

Check for the product name 'Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only'. Look for the lot numbers VR417062A, VR417063A, or VR417064A with expiration dates of 09/2019 or 10/2019.

  • Brand
    Jubilant Cadista
  • Category
    Drug
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Terminated
  • Distribution
    Product was distributed throughout the United States to wholesalers and retailers.
  • NDC
    59746-360-30, 59746-360-90, 59746-360-05, 59746-360-03, 59746-361-30, 59746-361-90, 59746-361-05, 59746-361-03, 59746-362-30, 59746-362-90, 59746-362-05, 59746-362-03, 59746-363-30, 59746-363-90, 59746-363-67, 59746-363-32
Recall numberProduct, codes & lotsQuantity
D-1103-2018Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30; Lot #: VR117014A, VR117015A, Exp. 08/201910,577 bottles
D-1104-2018Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90; Lot #: VR217013A, Exp. 08/20199,552 bottles
D-1105-2018Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90; Lot #: VR317040A, VR317041A, VR317042A, VR317043A, Exp. 08/201918,947 bottles
D-1106-2018Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90; Lot #: VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/20197,048 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the lot number and expiration date on the packaging to determine if it matches the recalled lots.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Product was distributed throughout the United States to wholesalers and retailers.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Aug 14, 201812. FDA classified it Class III: Aug 17, 201823. Published in FDA’s Enforcement Report: Aug 29, 201834. FDA terminated the recall: Jan 8, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1106-2018 (August 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1106-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA