openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodiethylamine (NDEA
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Code information
Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019
Distribution pattern
Product was distributed to major distribution chains throughout the United States.
drug · product 2 of 5
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodiethylamine (NDEA
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Code information
Lot Numbers: VFSA17007-A, exp. date Oct-2019
Distribution pattern
Product was distributed to major distribution chains throughout the United States.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodiethylamine (NDEA
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Code information
Lot Numbers: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 2020
Distribution pattern
Product was distributed to major distribution chains throughout the United States.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodiethylamine (NDEA
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Code information
Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
Distribution pattern
Product was distributed to major distribution chains throughout the United States.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodiethylamine (NDEA
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Code information
Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
Distribution pattern
Product was distributed to major distribution chains throughout the United States.
