Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.

Recall Insight

This FDA Drug action (record #D-0789-2020) was formally reported on January 22, 2020, with the manufacturer initiating the action on December 2, 2019. It is classified under Low severity (Class III), with a current status of Terminated. AuroMedics Pharma LLC is listed as the recalling firm, operating out of East Windsor, NJ. Federal records indicate 100,080 bottles units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. Distribution data in the federal record shows the product reached: Nationwide in the U.S.. 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 6 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.