FDA (Drugs) recall action 80836
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Jubilant Cadista Pharmaceuticals is recalling Valsartan tablets because an incorrect grade of excipient may have been used during manufacturing.
Jubilant Cadista Pharmaceuticals is recalling 18,947 bottles of Valsartan 160 mg tablets because an incorrect grade of excipient may have been used during manufacturing.
Jubilant Cadista Pharmaceuticals is recalling specific lots of Valsartan 40 mg tablets because an incorrect grade of excipient may have been used during manufacturing.
Jubilant Cadista Pharmaceuticals is recalling 7,048 bottles of Valsartan 320 mg tablets because an incorrect grade of excipient may have been used during manufacturing.