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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, wi…

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

Class II Medicine & devices FDA April 29, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Teva Pharmaceuticals USA, Inc — Parsippany, NJ
Severity
Class II — moderate
Reported
April 29, 2026
Quantity
5,101 cartons
Recall number
D-0521-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide in the USA, Puerto Rico and Virgin Islands

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