Exact FDA event identifier

Event 98672

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

Event summary

Timeline bucket: March 24, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: The Harvard Drug Group LLC

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

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61

D-0485-2026

Recall number: D-0485-2026
Initiated: March 24, 2026
Classification: Class II
Status: Ongoing
Recalling firm: The Harvard Drug Group LLC
Quantity: N/A

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lot # N02425, Exp Date: 05/31/2027.

Distribution pattern

US Nationwide.