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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 numberLots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
Where it was soldFL, OH, PR & MS
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 and Subpotent

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
NDC0591-2435-15
Show the full FDA record
Full product labelIsotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Recalling firmTeva Pharmaceuticals USA, Inc
DistributionFL, OH, PR & MS
Quantity21984 packages
Recall initiated2026-01-12
Report date2026-04-15
Recall completed—
Recall numberD-0445-2026
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.