FDA-Drug2026-04-29Not Yet ClassifiedCHEMICAL
Teva Claravis (isotretinoin) 10 mg recalled for elevated tretinoin impurity levels
What this means
Teva Pharmaceuticals is recalling specific lots of Claravis (isotretinoin) 10 mg capsules because they contain higher-than-allowed levels of tretinoin, a related chemical impurity. The affected lots are 100067507 and 100067508, which expire on July 31, 2026. No injuries have been reported so far.
- Check if you have Claravis 10 mg with lot number 100067507 or 100067508
- Contact your pharmacy or healthcare provider for instructions on returning the medication
- Do not stop taking your isotretinoin without speaking to your doctor first—they can provide a safe alternative
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA; Virgin Islands
Affected count
5,101 cartons
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=98730More Teva recalls
- FDA-Drug2026-09-09Teva trazodone 50 mg tablets recalled for foreign tablets in bottles
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