D-0446-2026 Class II Ongoing
FDA drug recall D-0446-2026 was initiated by Teva Pharmaceuticals USA, Inc on Jan 12, 2026 and is designated Class II. Reason for recall: Superpotent and Subpotent The recall status is ongoing. Affected quantity: 8376 packages.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 15, 2026
- Initiation Date
- Jan 12, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8376 packages
Product Description
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 for Recall
Superpotent and Subpotent
Distribution Pattern
FL, OH, PR & MS
Code Information
Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0446-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026