Dr. Berne's Whole Health Products

FDA Regulatory Profile

Dr. Berne's Whole Health Products appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0036-2024, Class II) was initiated on August 26, 2023.

Summary

Total Recalls
5 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0036-2024Class IIDr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health PAugust 26, 2023
D-0037-2024Class IDr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health PAugust 26, 2023
D-0035-2024Class IIDr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's WAugust 26, 2023
D-0034-2024Class IIDr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health PAugust 26, 2023
D-0033-2024Class IIDr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health August 26, 2023