Chaotic Labz Recalls MAYHEM Capsules Containing Undeclared Prescription Drugs
Chaotic Labz is recalling MAYHEM capsules because FDA analysis found undeclared dexamethasone and cyproheptadine, making the product an unapproved drug.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant health risks involving unapproved drugs.
Plain-English summary
Chaotic Labz is recalling 990 bottles of MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles. The affected product is identified by Lot number CLM061114 and expiration date 06/16. The product was distributed nationwide.
The recall was initiated because FDA analysis found that the product contains undeclared dexamethasone and cyproheptadine. These are FDA-approved drugs, which makes the product an unapproved drug marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased this product should stop using it and contact Chaotic Labz for further instructions.
The recalled product
- Product
- MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.
- Manufacturer
- Chaotic Labz
- Category
- Drug — Dietary Supplement
- Affected units
- 990
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#: CLM061114
- Exp 06/16
Distribution
Distributed nationwide across the United States.
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