# FDA recall D-0035-2024

> **Dr. Berne's Whole Health Products** · Class II · drug recall initiated 2023-08-26.

## Product

Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, Certified Organic by Organic Certifiers.

## Reason for recall

CGMP Deviations

## Distribution

Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

## Key facts

- **Recall number:** D-0035-2024
- **Recalling firm:** Dr. Berne's Whole Health Products
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-08-26
- **Report date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tesuque, NM, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0035-2024

## Citation

> AI Analytics. FDA recall D-0035-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0035-2024. Source: US FDA. Licensed CC0.

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