Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Product description
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Lot numbers, UPCs & expiration codes
Lots#: 100067507, 100067508, Exp 07/31/2026
Where it was sold
Nationwide in the USA, Puerto Rico and Virgin Islands
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-0521-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 6, 2026
- FDA report date
- Apr 29, 2026
- Quantity
- 5,101 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0521-2026, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98730
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lots#: 100067507, 100067508, Exp 07/31/2026
- Postal code
- 07054-1120
- Report date
- Apr 29, 2026
- Product type
- Drugs
- Recall number
- D-0521-2026
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 5,101 cartons
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Distribution pattern
- Nationwide in the USA, Puerto Rico and Virgin Islands
- Recall initiation date
- Apr 6, 2026
- Initial firm notification
- Letter
- Center classification date
- May 6, 2026