Skin Med Recalled for Superpotency

Teva Pharmaceuticals USA Inc. is recalling a single lot of isotretinoin capsules over concerns of superpotency. According to the April 17, 2024, US Food and Drug Administration (FDA) Enforcement Report, results from 3-month stability testing of the product were above specification limits.

The recall affects isotretinoin capsules, 40 mg, in 30-count cartons (carton NDC 0591-2436-15) containing 3 10-capsule blister packs (blister pack NDC 0591-2436-45), from lot 100044259 (Exp. 6/30/25). The product was manufactured for Teva Pharmaceuticals USA Inc., Parsippany, New Jersey, and was distributed throughout the United States.

Teva Pharmaceuticals USA voluntarily initiated the recall March 28, 2024. The FDA designated the recall a Class II on April 8, 2024. The classification communicates use of the affected drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Isotretinoin is a prescription retinoid used to treat severe nodular acne in patients unresponsive to conventional therapy, including systemic antibiotics.