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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77357

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

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Event summary

Timeline bucket
May 22, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Global Marketing Enterprises, 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

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

Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076

D-1096-2017
Recall number
D-1096-2017
Initiated
May 22, 2017
Classification
Class II
Status
Terminated
Quantity
52.5 kg

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
misbranded

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.

Code information

Batch # 15121931, 15121939, Exp 12/19

Distribution pattern

KY, VA, MI

Field note

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