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Azelaic Acid Gel 15%
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DRUG RECALLMODERATE

Azelaic Acid Gel 15%

Glenmark recalls Azelaic Acid Gel 15% over grainy/gritty texture complaints.

What to do

Check your tube for NDC 68462-626-52. Stop using the product and return it to the place of purchase or contact Glenmark for a refund or replacement.

Recalled
Listed
Updated
Recall No.
D-0731-2026
Agency
FDA
Firm
Glenmark Pharmaceuticals Inc., USA
Recall ID
99490
Status
ONGOING

Why it was recalled

Glenmark Pharmaceuticals is recalling Azelaic Acid Gel, 15%, 50 gram tubes, due to CGMP deviations involving abnormal texture or consistency complaints (grainy, gritty, or sandy).

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only

Lot code
19260937A, 2028
NDC / UPC
NDC 68462-626-52

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Manufacturing Deviation recalls

Other recent recalls from Glenmark Pharmaceuticals Inc., USA

All recalls from Glenmark Pharmaceuticals Inc., USA

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Editorial summary by Recall Canary · summary updated 2026-07-29 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification