Home » Indian Generics Maker Sun Pharma Recalls ED Meds in the U.S.
Indian Generics Maker Sun Pharma Recalls ED Meds in the U.S.
Drugs Postmarket Safety
Indian generics company Sun Pharmaceutical Industries is recalling more than 100,000 bottles in the U.S. of its generic tadalafil pills for the treatment of erectile dysfunction (ED).
The problem: the "incorrect grade" of inactive ingredient crospovidone that was added during production, according to the FDA's public notice about the recall.
The voluntary recall, which began Oct. 25, includes 30-count bottles of 5-mg and 20-mg doses. In total, the FDA said, that’s 73,957 bottles of the 5-mg version, and 36,786 bottles of the 20-mg pill.
The problem lots were made in India and shipped to one distributor in the U.S. that "may have” further released the product nationwide, the FDA said.