LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10

Recall Insight

This FDA Drug action (record #D-0253-2015) was formally reported on November 26, 2014, with the manufacturer initiating the action on September 22, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Micro Labs Usa, Inc S is listed as the recalling firm, operating out of Princeton, NJ. Federal records indicate 144 bottles units are affected.

The documented reason for this recall is: Failed Content Uniformity Specifications; Dry mix failed blend uniformity. Distribution data in the federal record shows the product reached: U.S. Including: New York. 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 12 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.