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Class II · ModerateActive recall

Claravis

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots#: 100067507, 100067508, Exp 07/31/2026
Where it was soldNationwide in the USA, Puerto Rico and Virgin Islands
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTeva Pharmaceuticals USA, Inc.
Brand nameCLARAVIS
Generic nameISOTRETINOIN
Active ingredient(s)ISOTRETINOIN
Distributed by / forTeva Pharmaceuticals USA, Inc
NDC0555-1054-56
Show the full FDA record
Full product labelClaravis (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., North Wales, PA 19454.
Recalling firmTeva Pharmaceuticals USA, Inc
DistributionNationwide in the USA, Puerto Rico and Virgin Islands
Quantity5,101 cartons
Recall initiated2026-04-06
Report date2026-04-29
Recall completed—
Recall numberD-0521-2026
ClassificationClass II
FDA statusOngoing
Origin on fileParsippany NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.