Exact FDA event identifier

Event 99194

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 08, 2026
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

1 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 1

Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.

D-0656-2026

Recall number: D-0656-2026
Initiated: June 08, 2026
Classification: Class II
Status: Ongoing
Recalling firm: ACCORD HEALTHCARE, INC.
Quantity: 6432 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 Drug

Code information

Lot # D2401522, Exp Date: 06/2026.

Distribution pattern

US Nationwide.