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Sun Pharma Fluocinonide Cream Recalled Over Viscosity Issues

🟑 MODERATE RISK — CLASS II
Agency: Food and Drug Administration (FDA)  |  Date: 20260422  |  Units: 41,712 30g tubes  |  Risk: Class II

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 28, 2026.

Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2. recalled by SUN PHARMACEUTICAL INDUSTRIES INC - Failed Viscosity Specifications:  Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Stock photo for illustration — not the actual recalled product. Photo by Danielle-Claude BΓ©langer on Unsplash

If your household uses Fluocinonide Cream, pay close attention. Sun Pharmaceutical Industries Inc. has issued a product recall in the United States that could affect your health.

Here's the Product That's Being Recalled

This recall involves a specific type of topical cream. We're talking about Fluocinonide, USP, 0.05% Cream, packaged in a 30g tube and available only with a prescription. It's manufactured by Taro Pharmaceuticals Inc. but distributed by Taro Pharmaceuticals U.S.A., Inc.

The product has the following identifiers:

  • NDC: 51672-1386-2
  • Lot Number: AD76251
  • Expiration Date: 6/30/2026

Check your medicine cabinet now. If you find a tube matching this description, keep reading.

What's Wrong With the Cream?

The cream isn't meeting quality standards. Specifically, it failed viscosity specifications during stability testing, meaning it's thicker than it should be. That might not sound like a huge deal, but it raised enough concern for the manufacturer to trigger a Class II recall.

A Class II recall means that using the affected product could cause a temporary health problem, or there is a slight chance of a serious health issue. Nobody wants that!

Where Was This Cream Sold?

This medicated cream was distributed widely. Based on the official recall notice, it was shipped nationwide across the U.S. That means American shoppers in nearly every state could have this product in their homes. You might have purchased it at your local pharmacy, or perhaps through a larger chain like CVS or Walgreens. While the recall details don't mention specific major retailers by name, the nationwide distribution suggests it could potentially be anywhere prescriptions are filled.

Approximately 41,712 of these 30g tubes are affected. That's a lot of potentially problematic cream circulating across the United States!

What You Should Do Right Now

Here's what to do if you have this cream.

  1. Immediately stop using the Fluocinonide Cream with the specified lot number and expiration date.
  2. Contact your healthcare provider or doctor to discuss alternative treatment options, especially if you've been using this cream for a skin condition.
  3. Safely dispose of the recalled tube of cream by returning it to the pharmacy where you purchased it, or by following your local guidelines for medication disposal.
  4. Keep this recall information handy in case you experience any adverse reactions or have further questions for your doctor about the potential impact of using the affected cream.

What Happens Next?

Sun Pharmaceutical Industries Inc. is working to resolve this issue. The company hasn't announced specific plans for replacements or refunds in the recall notice, so your first step should be talking to your doctor. They can advise you on the best course of action for your specific health needs.

This isn't the first time Sun Pharmaceutical has had to issue a recall. While previous recalls don't directly relate to this one, it's worth knowing that the FDA regularly monitors pharmaceutical manufacturers to ensure the safety of products sold across the U.S.

Frequently Asked Questions

Q: What does "failed viscosity specifications" actually mean?

It means the cream is thicker than it's supposed to be, according to Sun Pharmaceutical's internal standards. This change in consistency could potentially affect how the medicine is absorbed or how effectively it works.

Q: I've been using this cream for months; should I be worried?

You should contact your doctor or healthcare provider. They can assess any potential risks based on your individual health situation and how long you've been using the cream.

Q: Can I still use the cream if it looks and smells normal?

No, even if the cream appears normal, you should not use it. The viscosity issue was identified during stability testing, which is something you can't assess visually.

Q: Where can I find the lot number and expiration date on the tube?

Flip the tube of Fluocinonide Cream over. You'll find the lot number (Lot# AD76251) and expiration date (Exp Date: 6/30/2026) printed directly on the crimped end of the tube.

Q: What is a Class II recall?

According to the FDA, a Class II recall is issued when a product may cause a temporary or medically reversible health problem, or there is a remote chance of a serious health consequence.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.

⚠️ If You Own This Product:
Stop using it right away and follow the steps above. You may be entitled to a full refund, free repair, or replacement at no cost.
This article is based on official recall data from the Food and Drug Administration (FDA). Last verified on April 28, 2026.
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