Why it was recalled
Superpotent and Subpotent
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).
Lot numbers, UPCs & expiration codes
Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
Where it was sold
FL, OH, PR & MS
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0446-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 12, 2026
- FDA report date
- Apr 15, 2026
- Quantity
- 8376 packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0446-2026, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98275
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
- Postal code
- 07054-1120
- Report date
- Apr 15, 2026
- Product type
- Drugs
- Recall number
- D-0446-2026
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 8376 packages
- Reason for recall
- Superpotent and Subpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- FL, OH, PR & MS
- Recall initiation date
- Jan 12, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2026