Vasodilator Tablets Recalled

Sun Pharmaceutical Industries Inc is recalling three lots of tadalafil tablets because they contain an incorrect grade of the inactive pharmaceutical ingredient crospovidone, according to the November 17, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Sun Pharmaceutical Industries Limited, India, for Northstar Rx, Memphis, TN:

• 30-count bottles of tadalafil tablets, 5 mg (NDC 16714-075-01), from lot DNC1127A (Exp. 5/23), and
• 30-count bottles of tadalafil tablets, 20 mg (NDC 16714-077-01), from lots DNC0814A and DNC0815A (Exp. 4/23).

The tablets were sent to a distributor, who may have further distributed them throughout the United States.

Sun Pharmaceutical Industries voluntarily initiated the recall October 25, 2021. The FDA designated the recall Class II on November 12, 2021. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Tadalafil is a prescription medication used to treat erectile dysfunction and benign prostatic hyperplasia.