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Lower risk Drug recall · FDA · Published October 28, 2016

Sun Pharmaceutical KENALOG Spray Recall: Low Alcohol Content Risk

Sun Pharmaceutical recalls KENALOG (Triamcinolone Acetonide) Spray with low alcohol content that may not meet stability standards. This prescription-only spray was sold from 2016-2017 and requires checking lot numbers for affected batches.

🇺🇸 FDA recall #D-0148-2017DrugSun Pharmaceutical ›
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Recalling firmSun Pharmaceutical Industries, Inc.270 Prospect Plains Rd · Cranbury, NJ 08512-3605
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sun Pharmaceutical is recalling KENALOG (Triamcinolone Acetonide) spray due to unstable alcohol content that could affect safety. This prescription-only spray was sold between 2016 and 2017 and must be checked for specific lot numbers to determine if it's affected. Read more at govinfonow.com/recall/42271-sun-pharmaceutical-kenalog-spray-recall-low-alcohol-content-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/42271-sun-pharmaceutical-kenalog-spray-recall-low-alcohol-content-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0148-2017

Cite this page

“Sun Pharmaceutical KENALOG Spray Recall: Low Alcohol Content Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42271-sun-pharmaceutical-kenalog-spray-recall-low-alcohol-content-risk. Based on FDA recall #D-0148-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0148-2017%22&limit=1).

Why it’s dangerous

The spray's alcohol content may not meet stability specifications, which could lead to inconsistent medication delivery. This might affect how well the spray works for skin conditions but does not pose a direct risk of injury.

Who’s affected

Prescription patients who received KENALOG spray with lot numbers GHEN, GLGL, GLGL-1, HACS, HACS-1, HAFK, HAFK-1, HDBB, HDBB-1, HDFS, HDFS-1, HFDP, HFDP-1 from 2016-2017. Patients using this spray for skin conditions are most at risk if the alcohol content is unstable.

How to tell if you have this one

Check the lot numbers on the spray bottle: GHEN, GLGL, GLGL-1, HACS, HACS-1, HAFK, HAFK-1, HDBB, HDBB-1, HDFS, HDFS-1, or HFDP, HFDP-1. The spray was sold between 2016 and 2017 and is only available by prescription.

  • Brand
    Sun Pharmaceutical
  • Product
    Sun Pharmaceutical Industries, Inc. recalls KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for lot numbers GHEN, GLGL, GLGL-1, HACS, HACS-1, HAFK, HAFK-1, HDBB, HDBB-1, HDFS, HDFS-1, or HFDP, HFDP-1 on the spray bottle.

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: “NJ and further distributed Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Oct 28, 201612. FDA classified it Class III: Nov 22, 201623. Published in FDA’s Enforcement Report: Nov 30, 201634. FDA terminated the recall: Oct 20, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

What should I do if I have the recalled product?

The recall does not require immediate action. Check the lot number and contact your doctor if you have concerns about the spray's effectiveness.

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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-0148-2017 (October 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0148-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 9, 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