FDAClass II · Drug · Recall D-0731-2026 · Recalled August 5, 2026

Azelaic Acid Gel recall — Glenmark Pharmaceuticals Inc., USA

Agency report date: August 5, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Azelaic Acid Gel
Company / brand: Glenmark Pharmaceuticals
Lot / serial / date codes: Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
Distribution: Nationwide within the United States.

Agency product description and boundaries

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Azelaic Acid Gel

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0731-2026
Brand: Glenmark Pharmaceuticals
Classification: Class II
Units affected: N/A
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Azelaic Acid Gel

Companies & origin

Recalling firm location: Elmwood Park, NJ, United States
Firm address: 619 River Dr, N/A, 07407-1317

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
Distribution: Nationwide within the United States.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 99490
Recall initiated: July 23, 2026
FDA classified: July 28, 2026
FDA report date: August 5, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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