FDAHealthJanuary 12, 2026
Teva Pharmaceuticals USA, Inc — 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
⚠️ 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, 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).
- Brand
- ISOTRETINOIN
- Lot code
- 100075305
Additional details
Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8376 packages.
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