Drug Recall: 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
Teva Pharmaceuticals USA, Inc · April 6, 2026
Reason for Recall
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.
Distribution
Nationwide in the USA, Puerto Rico and Virgin Islands
States Affected
NATIONWIDE
Quantity Affected
5,101 cartons
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0521-2026
Status: ongoing
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