Claravis (isotretinoin capsule, USP), 10 mg

Teva Pharmaceuticals USA, Inc has recalled Claravis (isotretinoin capsule, USP), 10 mg, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 29, 2026 and was initiated on April 6, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Claravis (isotretinoin capsule, USP), 10 mg, with approximately 5,101 cartons affected. The company behind the recall is Teva Pharmaceuticals USA, Inc, based in Parsippany, NJ. The FDA describes the product as: “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.,…”

Why was Claravis (isotretinoin capsule, USP), 10 mg recalled?

According to the FDA, the stated reason for the recall is: “Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin.” In plain terms, this recall relates to a chemical impurity.

This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.

What should you do?

If you think you may have bought Claravis (isotretinoin capsule, USP), 10 mg, compare it against the product description and identifying codes (Lots#: 100067507, 100067508, Exp 07/31/2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Teva Pharmaceuticals USA, Inc or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.