The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0035-2024·Announced 2023-10-11

Drug eye drops recalled for manufacturing practice deviations nationwide

Dr. Berne's Organic Castor Oil Eye Drops are being recalled due to manufacturing practice deviations. The voluntary recall affects 1,744 bottles distributed nationally and internationally.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II drug recall for manufacturing practice deviations on a product applied directly to the eye, constituting a risk-of-harm product. No illnesses or injuries have been reported. Per the rubric, a High (3) severity reflects risk-of-harm products where injury has not yet been reported.

Plain-English summary

Dr. Berne's Organic Castor Oil Eye Drops, a 30 mL product distributed by Dr. Berne's Whole Health Products in Tesuque, New Mexico, have been voluntarily recalled due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall. A total of 1,744 bottles (Lot 6666, expiration 11/30/25) are affected.

The recalled product was distributed nationwide and to over 30 countries worldwide, including the United Kingdom, Canada, 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, and Barbados. The firm initiated the recall on August 26, 2023, and the FDA center made its classification on October 4, 2023.

The recalled product

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, [email protected], Certified Organic by Organic Certifiers.
Manufacturer
Dr. Berne's Whole Health Products
Category
Drug — Ophthalmic
Hazard
Affected units
1,744

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 6666
  • Exp. 11/30/25

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Dr. Berne's Whole Health Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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