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All product recalls associated with Dr. Berne's Whole Health Products.
Total Recalls
1000
Past Year
169
Class I (Serious)
125
Most Recent
Dec 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
CGMP Deviations
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
This recall involves Midwest Lubricants 99% Pure Sodium Hydroxide Caustic Soda Beads sold in a white 10-pound bottle. Midwest Lubricants, 99% Pure Sodium Hydroxide/Lye, and Caustic Soda Beads are printed on the red, blue, and white label.