Mineral Oil recalls

The FDA has published 4 recalls involving Mineral Oil since 2015. The latest was reported on 17 Aug 2022. Most were for particulate matter. Allergan Sales has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 17 Aug 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why mineral oil is recalled

Companies

Brands

By year

2022125%
2019125%
2015250%

All mineral oil recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
17 Aug 2022Drug	CLASS II	GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment recalledGenteal	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
27 Nov 2019Drug	CLASS II	ActivEyes Sterile Altalube Ointment recalled by Altaire PharmaceuticalsAltalube	Altaire Pharmaceuticals	Sterility	Nationwide
30 Sep 2015Drug	CLASS II	Refresh P.M. (Mineral Oil recalled by Allergan SalesRefresh P.m	Allergan Sales	Particulate Matter	Nationwide
30 Sep 2015Drug	CLASS II	Refresh Lacri-Lube (Mineral Oil recalled by Allergan SalesRefresh Lacri-lube	Allergan Sales	Particulate Matter	Nationwide

Should you stop taking Mineral Oil?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.