Beta Labs Recalls PHEnFX Dietary Supplement Containing Unapproved DMAA
Beta Labs is recalling 743 units of PHEnFX dietary supplements because they contain DMAA, a substance not permitted in dietary supplements.
The agency’s classification
FDA (Food): 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving unapproved substances in dietary supplements.
Plain-English summary
Beta Labs, LTD is recalling 743 units of PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES. The product was distributed nationwide and in the UK. The specific lot number is 1205129 with an expiration date of 12/16.
The recall is being conducted because the products contain DMAA (1,3-dimethylamylamine), also known as methylhexamine or geranium extract. The U.S. Food and Drug Administration states that DMAA is not permitted in dietary supplements.
Consumers who have 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
- PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559802
- Manufacturer
- Beta Labs
- Category
- Food — Dietary Supplement
- Affected units
- 743
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 (2)
- Lot # 1205129
- Exp 12/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Beta Labs under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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