Indian drug manufacturer Sun Pharmaceutical Industries has recalled more than 110,000 bottles of generic tadalafil pills in the American market due to manufacturing error, according to the latest enforcement report of the Food and Drug Administration (FDA).
Tadalafil is a medication used for the treatment of erectile dysfunction (ED) in men. Sold under the brand name Cialis, tadalafil belongs to a class of drugs called PDE-5 inhibitors, like sildenafil (Viagra), vardenafil (Levitra), and avanafil (Stendra).
Sun Pharma has recalled tadalafil pills in 30-count bottles of 5mg and 20 mg strengths. It recalled more than 73,900 bottles of tadalafil 5 mg and over 36,700 bottles of tadalafil 20 mg, the FDA said.
An affected lot of the medication was manufactured by the drug maker in India and distributed in the US by Princeton, New Jersey-based Sun Pharmaceutical Industries Inc, it said.
Explaining the reasons for the Class II recall, the FDA said, “An incorrect grade of crospovidone was used to manufacture the product.”
Crospovidone is an insoluble form of polyvinylpyrrolidone, and its use in the pharmaceutical industry as a tablet excipient (a tablet disintegrant and binder) has been widely documented, according to Science Direct.
The agency says a Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Sun Pharma initiated the nationwide recall on October 25, 2021.
Earlier this month, Sun Pharma had initiated a recall of 22,752 blister packs of Loratadine-D extended-release tablets, used for the treatment of allergic rhinitis and the common cold, in the US market, according to Business Insider.
The FDA said Sun Pharma has recalled the affected lot of generic tadalafil pills due to “failed moisture limits.”