James G. Cole Recalls I-C Drops Eye Cleansing Agent for Sterility Labeling
James G. Cole, Inc. is recalling I-C Drops Eye Cleansing Agent because the label does not state the product is sterile, as required by FDA regulations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling compliance issue regarding sterility assurance without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors or low-risk contamination.
Plain-English summary
James G. Cole, Inc. is recalling 253 bottles of I-C Drops, Eye Cleansing Agent, 15 ml. The product was distributed nationwide and in Canada.
The recall is due to a lack of assurance of sterility. The product label does not state "sterile" in accordance with 21 CFR Part 200.50(a)(1) and is not in compliance with 21 CFR Part 349 for ophthalmic drug products for over-the-counter use.
Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
- Manufacturer
- James G. Cole, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 253
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 (1)
- N/A
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02