High Performance Formulas recalls 120-count Cholestene capsules (1200mg red yeast rice per 2 capsules) due to being marketed without FDA approval. Consumers should check lot numbers and expiration dates.
Marketed Without an Approved NDA/ANDA
High Performance Formulas is recalling 120-count Cholestene capsules that contain red yeast rice. These capsules were sold without FDA approval, which means they may not be safe for use.
The capsules contain red yeast rice, which is not approved by the FDA. This means they may not be safe for use and could cause health issues, especially for people with certain medical conditions.
People who own or use Cholestene capsules with the specific lot number and expiration date mentioned in the recall. Those with medical conditions requiring cholesterol management may be at higher risk.
Check for the product name 'Cholestene capsules', 120-count bottle, with lot number #30317 and expiration date 02/2026. The manufacturer is High Performance Formulas, L.L.C.
Look for the lot number #30317 and expiration date 02/2026 on the product label.
The capsules were marketed without FDA approval, which means they may not be safe for use.
Check for the lot number #30317 and expiration date 02/2026 on the product label.
The recall does not specify a remedy, so contact the manufacturer for further instructions.
We’ve drafted a message you can send High Performance Formulas to request your refund or repair — edit it as you like.
Subject: Recall D-0727-2021 — High Performance Formulas High Performance Formulas Hello, I own a High Performance Formulas that is covered by recall D-0727-2021 from High Performance Formulas. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
