D-0861-2026 Class II Ongoing

Recalled by Sterling Pharmaceutical Services LLC — Dupo, IL

FDA drug recall D-0861-2026 was initiated by Sterling Pharmaceutical Services LLC on Aug 20, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 34368 tubes.

Recall Details

Product Type
Drugs
Report Date
Sep 30, 2026
Initiation Date
Aug 20, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34368 tubes

Product Description

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 Pattern

USA Nationwide

Code Information

Lot # 3183