Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97087

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 19, 2025
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

Complete imported group

Every recalled product in this event

2 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 2

Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

D-0507-2025
Recall number
D-0507-2025
Initiated
June 19, 2025
Classification
Class II
Status
Ongoing
Quantity
23,232 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container; blister packaging inadequately sealed.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container; blister packaging inadequately sealed.

Code information

Lot# M05205, Exp Date 10/2026

Distribution pattern

Nationwide

drug · product 2 of 2

Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0

D-0508-2025
Recall number
D-0508-2025
Initiated
June 19, 2025
Classification
Class II
Status
Ongoing
Quantity
3,527 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container; blister packaging inadequately sealed.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container; blister packaging inadequately sealed.

Code information

Lot# M05205A and M05205B, Exp Date 10/2026.

Distribution pattern

Nationwide