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Class III · Lower riskActive recall

Tretinoin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # AD96184, Exp Date: 12/31/2026.
Where it was soldUS Nationwide.
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

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 bySun Pharmaceutical Industries, Inc.
Brand nameTRETINOIN
Generic nameTRETINOIN
Active ingredient(s)TRETINOIN
Distributed by / forSUN PHARMACEUTICAL INDUSTRIES INC
NDC51672-1394-9
Show the full FDA record
Full product labelTretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionUS Nationwide.
QuantityN/A
Recall initiated2026-09-25
Report date2026-10-14
Recall completed—
Recall numberD-0033-2027
ClassificationClass III
FDA statusOngoing
Origin on filePrinceton 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.