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Lower risk Drug recall · FDA · Published January 27, 2026

Sun Pharmaceutical Diclofenac Gel Recall: Failed Viscosity Specifications

Sun Pharmaceutical Industries recalls Diclofenac Sodium Topical Gel 3% due to failed viscosity specifications. This may affect product stability and effectiveness.

🇺🇸 FDA recall #D-0342-2026DrugSun Pharmaceutical Industries ›
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Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC2 Independence Way · Princeton, NJ 08540-6620
✎ GovInfoNow plain-language explainer

Sun Pharmaceutical Industries is recalling Diclofenac Sodium Topical Gel 3% (100g tube) because it failed viscosity specifications. This could impact the product's stability and effectiveness, though serious injury risks are not described. Read more at govinfonow.com/recall/31500-sun-pharmaceutical-diclofenac-gel-recall-failed-viscosity-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/31500-sun-pharmaceutical-diclofenac-gel-recall-failed-viscosity-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0342-2026

Cite this page

“Sun Pharmaceutical Diclofenac Gel Recall: Failed Viscosity Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31500-sun-pharmaceutical-diclofenac-gel-recall-failed-viscosity-specifications. Based on FDA recall #D-0342-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0342-2026%22&limit=1).

The FDA announced on Jan. 27, 2026, that Sun Pharmaceutical Industries Inc. is recalling Diclofenac Sodium, Topical Gel, 3%, due to failed viscosity specifications. The recall affects lot AD92721 distributed nationwide.

How to tell if you have it

  • Brand: Sun Pharmaceutical Industries
  • Product: Diclofenac Sodium, Topical Gel, 3%, 100 g tube
  • NDC: 51672-1363-7
  • Lot #: AD92721
  • Exp Date: 3/31/2027

The hazard

The recalled Diclofenac Sodium Gel, 3% has viscosity results that are slightly lower than the specified limit. This out-of-specification result constitutes a failed viscosity specification.

Context

GovInfoNow's records show Sun Pharmaceutical Industries Inc. has 93 other recalls on record since May 21, 2013. Other recent recalls of similar products include Sun Pharmaceutical Nystatin Cream Recall (Sept. 14, 2026) and Sun Pharmaceutical Carbamazepine Tablets Recall (Aug. 3, 2026). Other recent recalls of similar products include Cipla Diclofenac Gel Recall (Dec. 22, 2025), Keystone Safco SensiCaine-Ultra Gel Recall (May 21, 2026), and Keystone DHP Topical Anesthetic Gel Recall (May 21, 2026).

How to tell if you have this one

Check for the product name 'Diclofenac Sodium, Topical Gel, 3%, 100 g tube', prescription-only, and the lot number AD92721 with expiration date 3/31/2027.

  • Brand
    Sun Pharmaceutical Industries
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name, lot number (AD92721), and expiration date (3/31/2027) to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

1. Firm started the recall: Jan 27, 202612. Published in FDA’s Enforcement Report: Feb 11, 202623. FDA classified it Class II: Feb 23, 202632026
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class II

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Sun Pharmaceutical Industries recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0342-2026 (January 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0342-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA