Fluocinonide Cream Recall by FDA
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 Fluocinonide cream due to failed viscosity specifications during stability testing, affecting 24,672 tubes distributed nationwide in the United States.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
The recall was initiated because Fluocinonide cream 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 15g tubes, with NDC 51672-1386-1, lot number AD76252, and expiration date of 6/30/2026. A total of 24,672 tubes are involved, distributed nationwide in the USA.
What You Should Do
Consumers should check if they have the affected lot and contact the recalling firm, Sun Pharmaceutical Industries Inc., at their address: 2 Independence Way, Princeton, NJ 08540-6620, for instructions on returns or refunds, as the recall was initiated via letter.
Why This Matters
This recall involves a prescription drug that failed quality specifications, potentially affecting its effectiveness and posing a risk of temporary health consequences, as classified by the FDA as a Class II recall.
Source
Attribution: FDA Recall Number D-0475-2026. For more information, visit the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,038 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.