FDA Recall of Fluocinonide Cream Over Viscosity Issues

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

The FDA has initiated a recall of 41,712 tubes of Fluocinonide cream due to failed viscosity specifications during stability testing.

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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Sun Pharmaceutical Industries Inc. is recalling Fluocinonide cream because it failed viscosity specifications, with out-of-specification results noted during stability testing. This is a Class II recall.

Which Products Are Affected

The affected product is Fluocinonide, USP, 0.05% Cream in 30g tubes. The National Drug Code (NDC) is 51672-1386-2, with other package NDCs including 51672-1386-1, 51672-1386-3, and 51672-1386-4. A total of 41,712 30g tubes are involved, specifically Lot# AD76251 with an expiration date of 6/30/2026. The product was distributed nationwide in the USA.

What You Should Do

Consumers should check if they have the affected product and follow the initial firm notification, which was sent via letter. Contact the recalling firm, Sun Pharmaceutical Industries Inc., for instructions on returns or refunds.

Why This Matters

This recall affects a prescription drug that may not perform as intended due to viscosity issues, potentially impacting treatment effectiveness for users in the United States.

Source

Attribution: FDA. Recall Number: D-0476-2026. For more information, visit the FDA website or search for the recall using the event ID 98677.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The FDA has initiated a recall of 41,712 tubes of Fluocinonide cream due to failed viscosity specifications during stability testing.
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.