Fluocinonide Cream Recall by Sun Pharmaceutical

Source: FDA · United States

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Sun Pharmaceutical Industries is recalling 2,640 tubes of Fluocinonide cream due to failed viscosity specifications during stability testing, affecting nationwide distribution in the USA.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Fluocinonide Cream Recall by Sun Pharmaceutical

What Happened

Sun Pharmaceutical Industries Inc. initiated a voluntary recall of Fluocinonide cream after it failed viscosity specifications, with out-of-specification results noted during stability testing.

Which Products Are Affected

The affected product is Fluocinonide, USP, 0.05% Cream in 60g tubes, with NDC 51672-1386-3. A total of 2,640 tubes are involved, specifically Lot# AD76250 with an expiration date of 6/30/2026. The product was distributed nationwide in the USA.

What You Should Do

Consumers should follow the firm's initial notification, which was sent via letter, and contact Sun Pharmaceutical Industries Inc. at their address: 2 Independence Way, Princeton, NJ 08540-6620, for information on returns or refunds related to this recall.

Why This Matters

This recall ensures the quality and safety of prescription medications, as the failed specifications could impact the product's effectiveness; it affects a specific lot of a widely used topical drug.

Source

This information is from the FDA recall notice, attributed to the U.S. Food and Drug Administration (FDA), with recall number D-0477-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Sun Pharmaceutical Industries is recalling 2,640 tubes of Fluocinonide cream due to failed viscosity specifications during stability testing, affecting nationwide distribution in the USA.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.