FDA Recalls Unapproved Caffeine Powder Marketed Without NDA Approval
Global Marketing Enterprises is recalling 52.5 kg of unapproved caffeine powder marketed with stimulant claims and lacking adequate directions for use.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
Global Marketing Enterprises, Inc. is recalling 52.5 kg of Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz). The product is packed by LifeLine Nutrients Corp and identified by Batch # 15121931 and 15121939 with an expiration date of 12/19.
The FDA has classified this recall as Class II because the product is an unapproved drug due to stimulant claims and is misbranded for failing to bear adequate directions for its intended use. The product was distributed in Kentucky, Virginia, and Michigan.
Consumers who purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Global Marketing Enterprises, Inc.
- Category
- Drug — Unapproved Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch # 15121931
- 15121939
- Exp 12/19
Distribution
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