Recall events
/
Event 81646
Event summary
Timeline bucket November 27, 2018
Product types Drug
Classifications Class II
Statuses Ongoing
Recalling firm wording Teva Pharmaceuticals USA
Dossier provenance
Source snapshots represented here
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.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
8 official enforcement rows
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 8
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0303-2019
Recall number D-0303-2019
Initiated November 27, 2018
Classification Class II
Status Ongoing
Quantity 120,394 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information NDC 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024
Distribution pattern USA Nationwide including Puerto Rico.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10583]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 8
Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0304-2019
Recall number D-0304-2019
Initiated November 27, 2018
Classification Class II
Status Ongoing
Quantity 39,617 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information NDC 0093-7691-56 & NDC 0093-7691-98 Lot # 24X012, 24X013
Distribution pattern USA Nationwide including Puerto Rico.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10579]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 8
Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0305-2019
Recall number D-0305-2019
Initiated November 27, 2018
Classification Class II
Status Ongoing
Quantity 75,883 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information NDC 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037
Distribution pattern USA Nationwide including Puerto Rico.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10594]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 8
Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0306-2019
Recall number D-0306-2019
Initiated November 27, 2018
Classification Class II
Status Ongoing
Quantity 142,260 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information NDC 0093-7693-56 & NDC 0093-7693-98 Lot # 26X036, 26X038, 26X039, 26X040, 26X041, 26X042, 26X043, 26X044, 26X045, 26X046, 26X047, 26X048, 26X049, 26X050, 26X051
Distribution pattern USA Nationwide including Puerto Rico.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10254]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 8
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0307-2019
Recall number D-0307-2019
Initiated November 27, 2018
Classification Class II
Status Ongoing
Quantity 41,572 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information NDC 0093-7807-56 & 0093-7807-98 Lot # 18X010, 18X011
Distribution pattern USA Nationwide including Puerto Rico.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10269]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 8
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0308-2019
Recall number D-0308-2019
Initiated November 27, 2018
Classification Class II
Status Ongoing
Quantity 19,458 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information NDC 0093-7810-56 & NDC 0093-7810-98 Lot # 20X006
Distribution pattern USA Nationwide including Puerto Rico.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10479]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 8
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0309-2019
Recall number D-0309-2019
Initiated November 27, 2018
Classification Class II
Status Ongoing
Quantity 37,957 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007
Distribution pattern USA Nationwide including Puerto Rico.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10610]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 8
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
D-0310-2019
Recall number D-0310-2019
Initiated November 27, 2018
Classification Class II
Status Ongoing
Quantity 31,079 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information All lots within expiry. NDC 0093-7809-56 & NDC 0093-7809-98
Distribution pattern USA Nationwide including Puerto Rico.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10112]
FDA event record
· Exact recall-number query on openFDA
