Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Aug 20, 2026 (2 months ago)

Major LubriFresh P.M. Nighttime Ointment

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

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 NDC 0904-6488-38

Compare with the code on your package — it is the most precise check available.

Recalling firm
Sterling Pharmaceutical Services LLC
NDC code
0904-6488-38
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0861-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other recalls by Sterling Pharmaceutical Services LLC

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Other sterility / contamination recalls from 2026

All sterility / contamination recalls