Valsartan Tablets (Jubilant Cadista) – Incorrect Excipient (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Valsartan 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
Brand
Jubilant Cadista Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot #: VR317040A, VR317041A, VR317042A, VR317043A, Exp. 08/2019
Products Sold
Lot #: VR317040A, VR317041A, VR317042A, VR317043A, Exp. 08/2019
Jubilant Cadista Pharmaceuticals, Inc. is recalling Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roor due to Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026