FDA (Drugs) recall action 88873
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
The agency’s own wording, quoted from the enforcement report.
Sun Pharmaceutical is recalling Tadalafil Tablets USP 20 mg due to use of an incorrect grade of Crospovidone during manufacturing. The recall affects 36,786 bottles distributed to one distributor.
Sun Pharmaceutical Industries is recalling Tadalafil 5 mg tablets (Lot # DNC1127A) because an incorrect grade of Crospovidone was used during manufacturing. The product was distributed to one distributor who may have further distributed it nationwide.