FDAFDA · Food and drugs·Recall number D-0445-2026
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).
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 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.