FDAFDA · Food and drugs·Recall number D-0446-2026
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).
Published April 15, 2026 · Recall initiated: January 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent and Subpotent
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ISOTRETINOIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- FL, OH, PR & MS
- Lot
- Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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