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Class II · ModerateActive recall

Major LubriFresh P.M. Nighttime Ointment

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 3183
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forMajor Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152
NDC0904-6488-38
Show the full FDA record
Full product labelMajor 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
Recalling firmSterling Pharmaceutical Services LLC
DistributionUSA Nationwide
Quantity34368 tubes
Recall initiated2026-08-20
Report date2026-09-30
Recall completed—
Recall numberD-0861-2026
ClassificationClass II
FDA statusOngoing
Origin on fileDupo IL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.