Teva Claravis isotretinoin capsules recalled for impurity levels
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.
From the FDA notice · Read the official notice ↗ · All Teva recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 5,101 cartons
- Illnesses reported
- None reported
- Manufactured in
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
- Classification
- Not Yet Classified
- Recall number
- 98730
In the FDA's words
- 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. Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Lots#: 100067507, 100067508, Exp 07/31/2026 Distribution: Nationwide in the USA; Virgin Islands Affected quantity: 5,101 cartons
- Hazard
- Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
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