The Recall Desk
SevereFDA (Drugs)·D-0861-2026·Announced 2026-09-30

Sterling Recalls Major LubriFresh P.M. Ointment for Sterility Concerns

Sterling Pharmaceutical Services LLC is recalling Major LubriFresh P.M. Nighttime Ointment due to a lack of assurance of sterility. The recall covers 34,368 tubes distributed nationwide.

What this means for you

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in a pharmaceutical product, which poses a risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Sterling Pharmaceutical Services LLC is recalling Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, due to a lack of assurance of sterility. The product is distributed by Major Pharmaceuticals and carries NDC 0904-6488-38.

The recall involves 34,368 tubes of Lot # 3183. These products were distributed nationwide in the United States.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

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
Affected units
34,368

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # 3183

Distribution

Distributed nationwide across the United States.