Eye Drops Bacterial and Fungal Contamination • Recall

FDA Publish Date:  August 26, 2023 Reason for Announcement:  Bacterial and Fungal Contamination Company Name:  Dr. Berne’s Whole Health Prod...

FDA Publish Date:  August 26, 2023

Reason for Announcement:  Bacterial and Fungal Contamination

Company Name:  Dr. Berne’s Whole Health Products

Brand Name:  Dr. Berne’s

Products on Recall:

• MSM 5% Solution Eye Drops
• MSM 15% Solution Eye Drops
• Castor Oil Eye Drops
• MSM MIST Drops 5% Solution

Risk Statement: Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, Dr. Berne’s has received 2 reports of adverse events related to this recall.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178