Dr. Reddy’s Laboratories is voluntarily recalling 765,018 cartons of its Zenatane (isotretinoin) capsules, an acne medicine, in three dose sizes, due to failed dissolution specifications in which out-of-specification results were observed for low dissolution.

The voluntary Class II recall was initiated on May 22, 2017 in the US, including Puerto Rico. 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.

The products were manufactured by Cipla at its plant in Pune, India.

The recalled dosage sizes of the product were: 89,118 cartons of 20-mg, 30-count (3 x 10 prescription packs) per carton; 223,650 cartons of 30-mg, 30-count (3 x 10 prescription packs) per carton; and 452,290 cartons of 40 mg, 30-count (3 x 10 prescription packs) per carton,

Source: US Food and Drug Administration: 89,118 cartons recall notice,;223,650 cartons recall notice; and 452,290 cartons recall notice