Teva Pharmaceuticals Usa, Inc: Isotretinoin Capsules, Usp, 30 Mg

Recall Summary Teva Pharmaceuticals is recalling Isotretinoin Capsules 30 mg due to quality issues where some batches are either stronger or weaker than they should be. The recall affects prescription packs distributed in Florida, Mississippi, Ohio, and Puerto Rico. Isotretinoin is a prescription medication used to treat severe acne.

Recalling firm

Teva Pharmaceuticals USA, Inc

Product

Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).

Reason

Superpotent and Subpotent

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-01-12

Status

Ongoing

Areas affected

FL, MS, OH

Distribution

FL, OH, PR & MS

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/5b6d407e-8b37-40d9-bc60-fdb05063b23a