Recall events
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Event 96194
Event summary
Timeline bucket January 29, 2025
Product types Drug
Classifications Class II
Statuses Ongoing
Recalling firm wording Glenmark Pharmaceuticals Inc., 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
14 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 14
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
D-0231-2025
Recall number D-0231-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 70,032 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.
Distribution pattern Nationwide within the U.S
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[17023]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 14
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
D-0232-2025
Recall number D-0232-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 56,208 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026.
Distribution pattern Nationwide within the U.S
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[16713]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 14
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
D-0233-2025
Recall number D-0233-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 175,920 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.
Distribution pattern Nationwide within the U.S
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[17026]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 14
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
D-0234-2025
Recall number D-0234-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 190,320 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026.
Distribution pattern Nationwide within the U.S
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[17030]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 14
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
D-0235-2025
Recall number D-0235-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 80,160 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026.
Distribution pattern Nationwide within the U.S
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[17024]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 14
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
D-0236-2025
Recall number D-0236-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 87,600 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19234153, Exp.: 9/2025; 19234900, 19234929, Exp.: 11/2025; 19240936, 19240942, Exp.: 2/2026; 19243199, 19243190, Exp.:7/2026; 19244013, 19244014, Exp.: 9/2026.
Distribution pattern Nationwide within the U.S
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[16980]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 14
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
D-0237-2025
Recall number D-0237-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 39,168 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026.
Distribution pattern Nationwide within the U.S
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[17258]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 14
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
D-0238-2025
Recall number D-0238-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 120,000 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026.
Distribution pattern Nationwide within the U.S
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[16679]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 14
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
D-0239-2025
Recall number D-0239-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 119,040 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025; 19241471, Exp.:3/2026; 19242180, Exp.: 5/2026.
Distribution pattern Nationwide within the U.S
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[16397]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 14
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
D-0240-2025
Recall number D-0240-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 133,824 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026.
Distribution pattern Nationwide within the U.S
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[17473]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 14
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
D-0241-2025
Recall number D-0241-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 233,040 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026.
Distribution pattern Nationwide within the U.S
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[16685]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 14
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
D-0242-2025
Recall number D-0242-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 53,952 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026.
Distribution pattern Nationwide within the U.S
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[16313]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 14
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
D-0243-2025
Recall number D-0243-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 58,416 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.
Distribution pattern Nationwide within the U.S
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[17247]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 14
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
D-0244-2025
Recall number D-0244-2025
Initiated January 29, 2025
Classification Class II
Status Ongoing
Quantity 58,368 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Atomoxetine Impurity
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: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026.
Distribution pattern Nationwide within the U.S
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[17236]
FDA event record
· Exact recall-number query on openFDA
