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
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Code information
Lot # 2A001, Exp. 01/15 Lot # 2A002, Exp. 01/15 Lot # 2C003, Exp. 03/15 Lot # 2F005, Exp. 06/15 Lot # 2G006, Exp. 07/15
Distribution pattern
Nationwide and Puerto Rico
drug · product 2 of 9
PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Code information
Lot # 2A002, Exp. 01/15 Lot # 2A003, Exp. 01/15 Lot # 2C004, Exp. 03/15 Lot # 2C005, Exp. 03/15 Lot # 2E008, Exp. 05/15 Lot # 2F009, Exp. 06/15 Lot # 2F010, Exp. 06/15 Lot # 2H011, Exp. 08/15 Lot # 2H012, Exp. 08/15 Lot # 2H013, Exp. 0815
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Code information
Lot # 2C002, Exp. 03/15 Lot # 2H004, Exp. 08/15 Lot # 2H006, Exp. 08/15
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
