Severity
Moderate
FDA Drug recall · Reported August 23, 2017
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 fa…
Global Marketing Enterprises, Inc. recalled Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 12… - a moderate-severity action.
Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 12… was recalled by Global Marketing Enterprises, Inc. in August 23, 2017. Reason: Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved …. Check the official notice for the remedy. Verify recall #D-1096-2017 with the FDA Drug before acting.
The recall
Global Marketing Enterprises, Inc. issued this moderate-severity FDA Drug recall-Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved ….
Sourced from official FDA Drug enforcement records. Verify recall #D-1096-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1096-2017) was formally reported on August 23, 2017, with the manufacturer initiating the action on May 22, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Global Marketing Enterprises, Inc. is listed as the recalling firm, operating out of Chicago, IL. Federal records list the affected scope as 52.5 kg.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: KY, VA, MI. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
52.5 kg
Related Recalls
6
5 from same agency
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
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1096-2017 |
| Date reported | August 23, 2017 |
| Date initiated | May 22, 2017 |
| Recalling firm | Global Marketing Enterprises, Inc. |
| Firm location | Chicago, IL |
| Affected scope | 52.5 kg |
| Distribution | KY, VA, MI |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported August 23, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.