Teva recalls Claravis 10mg isotretinoin capsules with specific impurity levels. These capsules may contain unsafe levels of tretinoin, posing a health risk. Consumers should check their product details and follow official instructions.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Teva is recalling Claravis 10mg isotretinoin capsules due to impurities that could be unsafe. This affects specific packaging lots from 2024 to 2026. The recall is important because improper use of these capsules could lead to health risks.
The capsules contain unsafe levels of tretinoin impurities, which could lead to health risks. This impurity issue is detected through quality control tests but may not be visible to the consumer.
People who have the specific Claravis 10mg capsules with NDC 0555-1054-56 or 0555-1054-86, purchased between 2024 and 2026, are affected. Those using isotretinoin for acne treatment are most at risk.
Check for the NDC codes 0555-1054-56 (100-count carton) or 0555-1054-86 (30-count carton). The capsules were manufactured in 2024 and expire by July 31, 2026.
Look for the NDC codes 0555-1054-56 or 0555-1054-86 on the packaging to confirm if your Claravis 10mg capsules are affected.
Teva is recalling Claravis 10mg capsules because they contain unsafe levels of tretinoin impurities that could pose health risks.
Check for the NDC codes 0555-1054-56 (100-count carton) or 0555-1054-86 (30-count carton) on the packaging.
The recall record does not specify a remedy, so contact Teva Pharmaceuticals USA, Inc. for further instructions.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0521-2026 — Teva Teva Hello, I own a Teva that is covered by recall D-0521-2026 from Teva. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
