Recall: D-0446-2026

Class II - Potentially Harmful

Class IIClassification

2026-01-12Initiated

OngoingStatus

Teva Pharmaceuticals USA, IncFirm

Product

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

Superpotent and Subpotent

Distribution

FL, OH, PR & MS

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.