Medications & Supplements/Topical Products

Dr. Berne's MSM Drops, Mist, and Castor Oil Eye Drops Recalled for Non-Sterility

Agency Publication Date: October 4, 2023

Summary

Dr. Berne's Whole Health Products is recalling 12,432 bottles of several eye care products, including MSM Drops (5% and 15% solutions), MSM Mist (15% solution), and Organic Castor Oil Eye Drops. These products are being recalled due to potential non-sterility and manufacturing deviations that do not meet safety standards. Using eye drops that are not sterile can cause serious eye infections, which may lead to irritation, discharge, or more severe complications.

Risk

The products were manufactured under conditions that failed to ensure sterility, creating a risk of bacterial contamination. If contaminated drops are applied to the eye, they can cause infections that may result in temporary or permanent vision loss.

What You Should Do

This recall affects Dr. Berne's MSM DROPS 5% and 15% Solution, MSM MIST 15% Solution, and Organic Castor Oil Eye Drops sold in 30 mL (1.014 oz or 1 fl oz) bottles.
Identify your product by checking the label for UPC 00854582001036 (MSM 15% Drops) or UPC 00854582001111 (MSM 5% Drops) and the specific lot numbers and expiration dates printed on the packaging.
Numerous lot numbers are affected. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer at hello@drsamberne.com for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dr. Berne's MSM DROPS 15% Solution (30 mL/1.014 OZ)

Variants: 15% Solution

UPC Codes:

00854582001036

Lot Numbers:

6486 (Exp: 11/23)

6536 (Exp: 01/24)

6549 (Exp: 02/24)

6561 (Exp: 03/24)

6623 (Exp: 06/24)

6630 (Exp: 06/24)

6646 (Exp: 07/24)

6675 (Exp: 09/24)

6686 (Exp: 09/24)

6695 (Exp: 10/24)

6738 (Exp: 11/24)

6767 (Exp: 01/25)

6787 (Exp: 03/25)

6799 (Exp: 04/25)

6832 (Exp: 05/25)

6844 (Exp: 05/25)

6857 (Exp: 06/25)

6888 (Exp: 07/25)

Distributed by Dr. Berne's Whole Health Products.

Product: Dr. Berne's MSM MIST 15% Solution (30 mL/1.014 OZ)

Variants: 15% Solution, Mist

Lot Numbers:

6617 (Exp: 05/24)

6623 (Exp: 06/24)

6646 (Exp: 07/24)

6675 (Exp: 09/24)

6716 (Exp: 11/24)

Distributed by Dr. Berne's Whole Health Products.

Product: Dr. Berne's Organic Castor Oil Eye Drops (30 mL/1 fl oz)

Variants: Organic, Castor Oil

Lot Numbers:

6666 (Exp: 11/30/25)

Certified Organic by Organic Certifiers.

Product: Dr. Berne's MSM DROPS 5% Solution (30 mL/1.014 OZ)

Variants: 5% Solution

UPC Codes:

00854582001111

Lot Numbers:

6485 (Exp: 11/23)

6562 (Exp: 03/24)

6624 (Exp: 06/24)

6669 (Exp: 08/24)

6688 (Exp: 09/24)

6727 (Exp: 11/24)

6771 (Exp: 02/25)

6830 (Exp: 03/25)

6887 (Exp: 07/25)

6786 (Exp: 03/31/25)

Distributed by Dr. Berne's Whole Health Products.

Product Images

Dr. Berne’s MSM Drops 5% Solution, outer box label

Dr. Berne’s MSM Drops Solution bottle

Dr. Berne’s MSM Drops 15% Solution, outer box label

Dr. Berne’s MSM Drops 5% Solution marketing photograph

Dr. Berne’s Organic Castor Oil Eye Drops bottle

Dr. Berne’s MSM MIST 15% Solution bottle

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92952

Status: Active

Manufacturer: Dr. Berne's Whole Health Products

Sold By: Dr. Berne's Whole Health Products

Manufactured In: United States

Units Affected: 4 products (6060 bottles; 795 bottles; 1744 bottles; 3833 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Dr. Berne's MSM DROPS 5% and 15% Solution, MSM MIST 15% Solution, and Organic Castor Oil Eye Drops sold in 30 mL (1.014 oz or 1 fl oz) bottles.

Identify your product by checking the label for UPC 00854582001036 (MSM 15% Drops) or UPC 00854582001111 (MSM 5% Drops) and the specific lot numbers and expiration dates printed on the packaging.

Numerous lot numbers are affected. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer at hello@drsamberne.com for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dr. Berne's MSM DROPS 15% Solution (30 mL/1.014 OZ)

Variants: 15% Solution

UPC Codes:

00854582001036

Lot Numbers:

6486 (Exp: 11/23)

6536 (Exp: 01/24)

6549 (Exp: 02/24)

6561 (Exp: 03/24)

6623 (Exp: 06/24)

6630 (Exp: 06/24)

6646 (Exp: 07/24)

6675 (Exp: 09/24)

6686 (Exp: 09/24)

6695 (Exp: 10/24)

6738 (Exp: 11/24)

6767 (Exp: 01/25)

6787 (Exp: 03/25)

6799 (Exp: 04/25)

6832 (Exp: 05/25)

6844 (Exp: 05/25)

6857 (Exp: 06/25)

6888 (Exp: 07/25)

Distributed by Dr. Berne's Whole Health Products.

Product: Dr. Berne's MSM MIST 15% Solution (30 mL/1.014 OZ)

Variants: 15% Solution, Mist

Lot Numbers:

6617 (Exp: 05/24)

6623 (Exp: 06/24)

6646 (Exp: 07/24)

6675 (Exp: 09/24)

6716 (Exp: 11/24)

Distributed by Dr. Berne's Whole Health Products.

Product: Dr. Berne's Organic Castor Oil Eye Drops (30 mL/1 fl oz)

Variants: Organic, Castor Oil

Lot Numbers:

6666 (Exp: 11/30/25)

Certified Organic by Organic Certifiers.

Product: Dr. Berne's MSM DROPS 5% Solution (30 mL/1.014 OZ)

Variants: 5% Solution

UPC Codes:

00854582001111

Lot Numbers:

6485 (Exp: 11/23)

6562 (Exp: 03/24)

6624 (Exp: 06/24)

6669 (Exp: 08/24)

6688 (Exp: 09/24)

6727 (Exp: 11/24)

6771 (Exp: 02/25)

6830 (Exp: 03/25)

6887 (Exp: 07/25)

6786 (Exp: 03/31/25)

Distributed by Dr. Berne's Whole Health Products.