Teva Pharmaceuticals USA, Inc recalls Isotretinoin Capsules
- Recalling company
- Teva Pharmaceuticals USA, Inc
- 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).
- Reason
- Superpotent and Subpotent
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 12, 2026
- Reported
- Apr 15, 2026
- Distribution
- FL, OH, PR & MS
- Status
- Ongoing
- Quantity
- 8376 packages
- Lot / codes
- Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
- Company location
- Parsippany, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0446-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0446-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.