Class IIDrug
Major LubriFresh P.M recall
Summary
Sterling Pharmaceutical Services LLC is recalling Major LubriFresh P.M. Nighttime Ointment (drug). According to the FDA report, the reason is: Lack of Assurance of Sterility. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Reason
- Lack of Assurance of Sterility
- Lot / code info
- Lot # 3183
- Quantity
- 34368 tubes
- Distribution
- USA Nationwide
- Recalling company
- Sterling Pharmaceutical Services LLC, Dupo, IL United States
- Recall started
- August 20, 2026
- FDA report date
- September 30, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0861-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Sterling Pharmaceutical Services LLC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.