Recall
FDAHealthJanuary 12, 2026

Teva Pharmaceuticals USA, Inc — 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

⚠️ Superpotent and Subpotent

Is this relevant to me?

Geography
FL, OH, PR, MS
Source agency
FDA
Category
Health
Published
January 12, 2026

FL, OH, PR & MS

What's affected?

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).
Lot code
100055426

Additional details

Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 21984 packages.

View original FDA notice →

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