Teva Pharmaceuticals USA, Inc recalls Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc…

Recall date

January 12, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0446-2026

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA, Inc

Sold / distributed

FL, OH, PR & MS

Why it was recalled

Superpotent and Subpotent

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).