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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96416

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

Open FDA event record

Event summary

Timeline bucket
March 04, 2025
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

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

Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.

D-0304-2025
Recall number
D-0304-2025
Initiated
March 04, 2025
Classification
Class III
Status
Terminated
Quantity
224 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

Code information

Lot# T05393, Exp. Date: 09/30/2025

Distribution pattern

Nationwide in the USA