Class II
Terminated
Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.
This recall has been terminated (originally issued May 28, 2014).
- Recall Initiated
- April 29, 2014
- Posted
- May 28, 2014
- Recall Number
- D-1349-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 209 bottles and b) 8 bottles
- Firm Location
- Eugene, OR, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: 1402009; 1312008; 1309017; and 1308009
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026