Eyebright Topical Eye Rinse (Wise Woman Herbals) – Sterility Concern (2013)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
Brand
Earthlabs, Inc. DBA Wise Woman Herbals
Lot Codes / Batch Numbers
2EDCO, 4EDCO, 8EDCO, 16EDCO, 2 oz., 4 oz. Non-stock: 8 oz., 16 oz., 32 oz.
Products Sold
Lot# 10010 Best used by: 07/14/13 Lot# 10285 Best used by: 02/16/14 Lot# 10640 Best used by: 11/09/14 Lot# 11107 Best used by: 09/16/15 Lot# 11408 Best used by: 05/04/16 Lot# 11711 Best used by: 11/23/16 Lot# 12088 Best used by: 09/04/17 Each lot number has various sizes Product numbers - 1EDCO, 2EDCO, 4EDCO, 8EDCO, 16EDCO, 32EDCO 1 (indicates package size) ED (indicates Eyebright) CO (indicates compound (blended from other finished products) Container sizes - Stock: 1 oz., 2 oz., 4 oz. Non-stock: 8 oz., 16 oz., 32 oz.
Earthlabs, Inc. DBA Wise Woman Herbals is recalling Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed due to Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug prod. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026