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healthClass IIRecalled on Oct 1, 2025

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India

🔢 13824 tubes

Sold At: Glenmark Pharmaceuticals Inc., USA(Nationwide within the United States)

Recall #: FDA-DRUG-D-0662-2025

Source: FDA-ENFORCEMENT

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India

Product Identification

Lot/Batch Codes:
Batch # 19252524, Exp Date: May 2027

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Summary

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

What to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact Glenmark Pharmaceuticals Inc., USA for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.