Reported Oct 1, 2025 · Ongoing

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited…

Glenmark Pharmaceuticals Inc., USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

  • Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only
  • Manufactured byGlenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India
  • Manufactured forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
Lot codes and dates
  • Batch # 19252524
  • Exp DateMay 2027
Amount recalled
13824 tubes

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Market complaints received for gritty texture (grainy)

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:18 PM UTC

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