Medications & Supplements/Prescription Drugs

Claravis (isotretinoin) Capsules Recalled for Impurity Specifications

Agency Publication Date: April 17, 2026

Summary

Teva Pharmaceuticals USA, Inc. has voluntarily recalled 5,101 cartons of Claravis (isotretinoin) 10 mg capsules due to a specific impurity (tretinoin) that fell out of the required quality specifications. Claravis is a prescription medication used to treat severe acne. This recall affects 100-count and 30-count cartons distributed nationwide and in the Virgin Islands.

Risk

The product was found to contain levels of the impurity Tretinoin that exceed approved specifications, which may affect the medication's quality and consistency. No incidents or injuries have been reported to date.

What You Should Do

Check your medication carton and blister packs for NDC 0555-1054-56 (100-count carton), NDC 0555-1054-86 (30-count carton), or NDC 0555-1054-60 (blister packs).
Look for lot numbers 100067507 or 100067508 with an expiration date of 07/31/2026.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Claravis (isotretinoin capsule, USP), 10 mgby Claravis

Variants: 10 mg, Capsule

Lot Numbers:

100067507 (Exp 07/31/2026)

100067508 (Exp 07/31/2026)

NDC:

0555-1054-56

0555-1054-86

0555-1054-60

Packaged as 100-count cartons (10x10 blisters) and 30-count cartons (3x10 blisters).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98730

Status: Active

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5,101

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication carton and blister packs for NDC 0555-1054-56 (100-count carton), NDC 0555-1054-86 (30-count carton), or NDC 0555-1054-60 (blister packs).

Look for lot numbers 100067507 or 100067508 with an expiration date of 07/31/2026.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.