FDA Recall D-0446-2026
Teva Pharmaceuticals USA, Inc · Parsippany, NJ
Class II Ongoing 122 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Superpotent and Subpotent
Recall record
- Recall number
D-0446-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- FL, OH, PR & MS
- Recall initiated
- 2026-01-12
- Classified by FDA Center
- 2026-04-08
- FDA published
- 2026-04-15
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Firm location
- Parsippany, NJ
Drug identification
- Brand name(s)
- ISOTRETINOIN
- Generic name(s)
- ISOTRETINOIN
- Manufacturer(s)
- Actavis Pharma, Inc.
- NDC(s)
0591-2433, 0591-2434, 0591-2451, 0591-2435, 0591-2501, 0591-2436- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.