Jubilant Cadista Pharmaceuticals, Inc. is recalling approximately 46,124 bottles of Valsartan Tablets USP (brand name Valsartan) in 40 mg, 80 mg, 160 mg, and 320 mg strengths. The recall was issued because a potential incorrect grade of an inactive ingredient (excipient) was used during the manufacturing process. The affected medication was distributed nationwide to wholesalers and retailers throughout the United States.
The use of an incorrect grade of an inactive ingredient can potentially affect the quality or manufacturing consistency of the drug. While this is considered a low-risk Class III recall, it involves a deviation from standard manufacturing requirements.
Pharmacy refund and guidance.
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Sources: FDA iRES · Raw API Response
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