Class IIOngoing

Isotretinoin Capsules recall

FDA recall D-0446-2026 · initiated Jan 12, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Superpotent and Subpotent

Details

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).
Recalling company: Teva Pharmaceuticals USA, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: FL, OH, PR & MS
Initiated: Jan 12, 2026
FDA report date: Apr 15, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0446-2026 ↗

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