Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

Recall Insight

This FDA Drug action (record #D-0387-2022) was formally reported on January 26, 2022, with the manufacturer initiating the action on January 14, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Mayne Pharma Inc is listed as the recalling firm, operating out of Greenville, NC. Federal records indicate 17,113 canisters units are affected.

The documented reason for this recall is: CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.