FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.

Recall Insight

This FDA Drug action (record #D-1819-2015) was formally reported on September 30, 2015, with the manufacturer initiating the action on August 24, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Allergan Sales, LLC is listed as the recalling firm, operating out of Waco, TX. Federal records indicate 28,292 tubes units are affected.

The documented reason for this recall is: Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially intr… Distribution data in the federal record shows the product reached: Nationwide, Puerto Rico, and Barbados. 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 5 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 11 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.