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.
drug · product 1 of 5
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
foreign substance
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Code information
Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Date 6/30/27, AM241086, Exp Date 7/31/27, AM241087, AM241088, Exp Date 8/31/27.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
foreign substance
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
foreign substance
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Code information
Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
foreign substance
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Code information
Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
foreign substance
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
