CLASS II ONGOING Drug recall · Reported 30 Sep 2026 · FDA Enforcement Report
Major LubriFresh P.M. Nighttime Ointment recalled
Sterling Pharmaceutical Services is recalling Major LubriFresh P.M. Nighttime Ointment, distributed nationwide in the US. The recall was initiated on 20 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0861-2026
- FDA event ID
- 99712
- Recalling firm
- Sterling Pharmaceutical Services, Dupo, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2026
- FDA classified
- 21 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 20 Aug 2026 | Recall initiated by company | |
| 21 Sep 2026 | Classified by FDA | +32 days |
| 30 Sep 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # 3183
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 99712This product is part of a recall event; the main page for the event is TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recalled.
More recalls from Sterling Pharmaceutical Services
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Reliable-1 Laboratories Lubricating Tears, Sterile recalledLubricating Tears | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Lubricant Eye Drops recalled by Sterling PharmaceuticalWalgreens Lubricant Eye Drops | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Lubricant Eye Drops Total Twin Pack recalledWalgreens Lubricant Eye Drops | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Reliable -1 Laboratories, Sodium Chloride Hypertonicity recalledSodium Chloride Hypertonicity Ophthalmic Solution, 5% | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Lubricant Eye Drops-Cameron Pharmaceuticals recalled | Sterling Pharmaceutical Services | Sterility | Nationwide |