Reported Oct 14, 2026 · Ongoing

Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,…

Sun Pharmaceutical Industries Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Tretinoin Cream USP, 0.05%, 45g tube, Rx only
  • Mfd byTaro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist
  • byTaro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9
Lot codes and dates
  • Lot # AD96184
  • Exp Date12/31/2026

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Nov 4, 1:00 AM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.