CLASS II Drug recall · Reported 23 Aug 2017 · FDA Enforcement Report
Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine recalled
Global Marketing Enterprises is recalling Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, distributed in Kentucky, Michigan, Virginia. The recall was initiated on 22 May 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1096-2017
- FDA event ID
- 77357
- Recalling firm
- Global Marketing Enterprises, Chicago, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2017
- FDA classified
- 17 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Drug class
- Veterinary Drugs
Timeline
| 22 May 2017 | Recall initiated by company | |
| 17 Aug 2017 | Classified by FDA | +87 days |
| 23 Aug 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
KY, VA, MI
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Batch # 15121931, 15121939, Exp 12/19
Where was it sold?
KY, VA, MI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Global Marketing Enterprises
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | kg/lb) Farm Raised Head-On Shrimps, Keep Frozen recalled | Global Marketing Enterprises | Undeclared Sulfites | 5 states |
Other Caffeine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Caffeine Tablet, 200 mg, Over The Counter recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |