Recall events
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Event 96666
Event summary
Timeline bucket April 10, 2025
Product types Drug
Classifications Class II
Statuses Ongoing
Recalling firm wording ACCORD HEALTHCARE, INC.
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
4 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 4
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
D-0394-2025
Recall number D-0394-2025
Initiated April 10, 2025
Classification Class II
Status Ongoing
Quantity 4,888 Bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent
Code information Lot # D2300323, Exp Date: 01/2026
Distribution pattern Nationwide US.
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[16457]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.
D-0395-2025
Recall number D-0395-2025
Initiated April 10, 2025
Classification Class II
Status Ongoing
Quantity 4,872 Bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent
Code information Lot # D2400547, Exp Date: 02/2026
Distribution pattern Nationwide US.
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[17466]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17
D-0396-2025
Recall number D-0396-2025
Initiated April 10, 2025
Classification Class II
Status Ongoing
Quantity 4,885 Bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent
Code information Lot # D2300044, Exp Date: 12/2025
Distribution pattern Nationwide US.
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[16786]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15
D-0397-2025
Recall number D-0397-2025
Initiated April 10, 2025
Classification Class II
Status Ongoing
Quantity 18,984 Bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent
Code information Lot # D2400725, Exp Date: 03/2026
Distribution pattern Nationwide US.
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[16804]
FDA event record
· Exact recall-number query on openFDA
