Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042

Recall Insight

This FDA Drug action (record #D-0665-2024) was formally reported on October 2, 2024, with the manufacturer initiating the action on September 16, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. AbbVie Inc. is listed as the recalling firm, operating out of North Chicago, IL. Federal records indicate 763,426 tubes units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Distribution data in the federal record shows the product reached: Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 1 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.