FDA recall D-0861-2026

Sterling Pharmaceutical Services LLC · Class II · drug

Product

Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38

Reason for recall

Lack of Assurance of Sterility

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2026-08-20
Report date: 2026-09-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dupo, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0861-2026