LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

Recall Insight

This FDA Drug action (record #D-1114-2019) was formally reported on April 17, 2019, with the manufacturer initiating the action on February 28, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Torrent Pharma Inc. is listed as the recalling firm, operating out of Basking Ridge, NJ. Federal records indicate 133,992 bottles units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. Distribution data in the federal record shows the product reached: Nationwide USA and Puerto Rico. 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 7 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.