Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30

Recall Insight

This FDA Drug action (record #D-0361-2019) was formally reported on January 23, 2019, with the manufacturer initiating the action on December 31, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Aurobindo Pharma USA Inc. is listed as the recalling firm, operating out of East Windsor, NJ. Federal records indicate 18,408 bottles units are affected.

The documented reason for this recall is: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. Distribution data in the federal record shows the product reached: Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.. 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.