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Class II · ModerateActive recall

Isotretinoin

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

Does this affect you?
Check your lot numberLot #: 100044259, Exp 06/30/2025.
Where it was soldNationwide in the USA
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

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

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 byActavis Pharma, Inc.
Brand nameISOTRETINOIN
Generic nameISOTRETINOIN
Active ingredient(s)ISOTRETINOIN
Distributed by / forTeva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack
NDC0591-2436-45
Show the full FDA record
Full product labelIsotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Recalling firmTeva Pharmaceuticals USA, Inc
DistributionNationwide in the USA
Quantity5,304 3x10-cartons
Recall initiated2024-03-28
Report date2024-04-17
Recall completed—
Recall numberD-0439-2024
ClassificationClass II
FDA statusOngoing
Origin on fileParsippany NJ United States

Related

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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.