MedicineWatch US
Class II Recall

Teva Pharmaceuticals USA, Inc

Product
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Reason
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Classification
Class II
Status
Ongoing
Lot
Lot #: 100044259, Exp 06/30/2025.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Teva Pharmaceuticals USA, Inc — Class II Recall | MedicineWatch US