D-0446-2026 Class II Ongoing

Recalled by Teva Pharmaceuticals USA, Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
April 15, 2026
Initiation Date
January 12, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8376 packages

Product Description

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).

Reason for Recall

Superpotent and Subpotent

Distribution Pattern

FL, OH, PR & MS

Code Information

Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .