FDA recall, , Moderate risk
Teva Claravis Isotretinoin Capsules
Claravis (isotretinoin capsule, USP), 10 mg, failed impurities/degradation specifications for specific impurity Tretinoin.
Summary by Recall Canary from the FDA notice
What happened
Teva Pharmaceuticals USA, Inc., of Parsippany, New Jersey, recalled Claravis (isotretinoin capsule, USP), 10 mg, because it failed impurities/degradation specifications for the specific impurity Tretinoin. The recall began April 6, 2026, and was added to the FDA's Enforcement Report on April 17, 2026. The product was distributed nationwide in the USA, Puerto Rico, and the Virgin Islands.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Claravis (isotretinoin capsule, USP), 10 mg
- NDC
- 0555-1054-56
- 0555-1054-60
- 0555-1054-86
- UPC
- 100067507
- 100067508
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
Nationwide in the USA, Puerto Rico and Virgin Islands
- Company
- Teva Pharmaceuticals USA, IncParsippany, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98730
- Recall number
- D-0521-2026
- Quantity recalled
- 5,101 cartons
All recalls from Teva Pharmaceuticals USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
