Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177
Summary
The FDA issued a Class II for Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distr by Sterling Pharmaceutical Services LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0861-2026
Action Date
2026-09-30
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot # 3183
Quantity Affected: 34368 tubes
Reason for Recall
Lack of Assurance of Sterility
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-20
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 26 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Sterling Pharmaceutical Services LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sterling Pharmaceutical Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sterling Pharmaceutical Services LLC have FDA actions?
Sterling Pharmaceutical Services LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0861-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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