Recall events
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Event 95660
Event summary
Timeline bucket November 01, 2024
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
6 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 6
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.
D-0093-2025
Recall number D-0093-2025
Initiated November 01, 2024
Classification Class II
Status Ongoing
Quantity 34848 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-Desmethyl-Diltiazem 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-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information Lot #s: 17222544, Exp. Date 11/30/2024 ; 17230784, Exp Date 03/31/2025; 17231080, Exp. Date 04/30/2025
Distribution pattern Nationwide in the USA
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[16755]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 6
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
D-0094-2025
Recall number D-0094-2025
Initiated November 01, 2024
Classification Class II
Status Ongoing
Quantity 12,864 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-Desmethyl-Diltiazem 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-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
Distribution pattern Nationwide in the USA
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[16761]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 6
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
D-0095-2025
Recall number D-0095-2025
Initiated November 01, 2024
Classification Class II
Status Ongoing
Quantity 25584 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-Desmethyl-Diltiazem 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-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information Lot #: 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.
Distribution pattern Nationwide in the USA
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[16911]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 6
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.
D-0096-2025
Recall number D-0096-2025
Initiated November 01, 2024
Classification Class II
Status Ongoing
Quantity 5232 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-Desmethyl-Diltiazem 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-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information Lot #: 17222544, Exp 11/30/2024.
Distribution pattern Nationwide in the USA
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[17477]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 6
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.
D-0097-2025
Recall number D-0097-2025
Initiated November 01, 2024
Classification Class II
Status Ongoing
Quantity 4704 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-Desmethyl-Diltiazem 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-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information Lot #: 17222452, Exp Date 11/30/2024; 17230607, Exp Date 02/28/2025.
Distribution pattern Nationwide in the USA
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[17250]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 6
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.
D-0098-2025
Recall number D-0098-2025
Initiated November 01, 2024
Classification Class II
Status Ongoing
Quantity 7296 bottles
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-Desmethyl-Diltiazem 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-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information Lot #:17222547, Exp. Date, 11/30/2024; 17230598, Exp. Date 02/28/2025
Distribution pattern Nationwide in the USA
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[141]
FDA event record
· Exact recall-number query on openFDA
