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Claravis (isotretinoin capsule, USP) 10 mg
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DRUG RECALLMODERATE

Claravis (isotretinoin capsule, USP) 10 mg

Teva is recalling Claravis 10 mg capsules (NDC 0555-1054-56, 0555-1054-86) due to out-of-specification Tretinoin impurity levels.

What to do

Do not use this medication. Contact your pharmacy or healthcare provider immediately for a replacement or alternative treatment. Return the recalled product to your pharmacy.

Recalled
Listed
Updated
Recall No.
N/A
Agency
FDA
Firm
Teva Pharmaceuticals USA, Inc
Recall ID
98730
Status
ONGOING

Recall at a glance

Quantity recalled
5,101 cartons

Why it was recalled

Teva Pharmaceuticals USA, Inc. is recalling Claravis (isotretinoin capsule, USP) 10 mg in 100-count cartons (NDC 0555-1054-56) and 30-count cartons (NDC 0555-1054-86) distributed nationwide and in the Virgin Islands due to out-of-specification levels of the impurity Tretinoin. Affected blister packs are NDC 0555-1054-60.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Claravis (isotretinoin capsule, USP)Lot code: 100067507, 100067508, 2026Strength: 10 mgUPC: 100067507, 100067508

Recall #
N/A
D-0521-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-05-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification