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FDAFDA · Food and drugs·Recall number D-0861-2026

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

Published September 30, 2026 · Recall initiated: August 20, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Lack of Assurance of Sterility

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Sterling Pharmaceutical Services LLC
Distributor
USA Nationwide
Lot
Lot # 3183
Risk classification
Class II
Area (FDA)
drug
Country
United States

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Questions about this recall

Was 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 recalled?

Yes. FDA published recall D-0861-2026 on September 30, 2026. Reported hazard: Lack of Assurance of Sterility

What should I do if I have this product?

Voluntary: Firm initiated · Letter

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