Exact FDA event identifier

Event 97936

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

Event summary

Timeline bucket: November 05, 2025
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Lupin Pharmaceuticals 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

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

D-0227-2026

Recall number: D-0227-2026
Initiated: November 05, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: 52,128 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective container - seal not adhering to bottles

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container - seal not adhering to bottles

Code information

Lot # QB00865, exp. date Feb 2028

Distribution pattern

Nationwide.