FDA lists Class II recall of Delta Foremost Sani-Foam Mango over CGMP deviations
An FDA enforcement report entry records an ongoing Class II recall of Delta Foremost Sani-Foam Mango, made by Abc Compounding Co., Inc., and distributed across the US.
The US Food and Drug Administration has published a Class II recall entry for Delta Foremost Sani-Foam Mango, a product from Abc Compounding Co., Inc. The entry is dated 4 November 2026 and carries recall number D-0090-2027.
The stated reason for the recall is deviations from current good manufacturing practice (CGMP). The recall status is listed as ongoing, meaning the action had not been closed at the time of the report.
The product was distributed nationwide in the United States. The material available for this article does not give the specific CGMP deviations, the affected lots or expiry dates, the quantity of product involved or the date the recall began.
Under FDA's classification system, a Class II recall covers situations where use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.
What it means for your team
- Quality teams at compounders and their contract partners should note that CGMP deviations alone can lead to an FDA-classified recall, even with no adverse events reported in the entry.
- Distributors and customers handling Delta Foremost Sani-Foam Mango should check the full FDA enforcement report record for lot and code information, which is not set out in the available text.
- Regulatory affairs teams may wish to track the recall's status, which is currently ongoing, for any later update or termination.
Official source: FDA enforcement report ↗
Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.