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).
- Brand
- ISOTRETINOIN
- 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.
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