Teva Pharmaceuticals USA, Inc recalls Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a)
See all recalls from Teva Pharmaceuticals USA, Inc →Recalled 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.
Hazard / Issue
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lots#: 100067507, 100067508, Exp 07/31/2026
✅ What Should You Do?
- 1Stop taking this medication and contact your doctor or pharmacist immediately.
- 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
- 3Check the lot number on your bottle or packaging against the recalled lots listed above.
- 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Claravis (isotretinoin capsule, USP), →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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