Fluocinonide Cream Recall by FDA
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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 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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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 ↗
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