Recall of BioGlo Fluorescein Sodium Strips Cites Manufacturing Compliance Concerns

Key Takeaways

• BioGlo Fluorescein Sodium Ophthalmic Strips USP (NDC 17238-900-11), all lots, are under a nationwide Class II recall affecting 184 320 containers due to sterility concerns.
• The recall was voluntarily initiated on December 31, 2025, and classified by the US Food and Drug Administration (FDA) on February 25, 2026, citing lack of assurance of sterility and nonconformance with current good manufacturing practices (CGMP) requirements.
• The diagnostic strips are used to detect corneal abrasions and other ocular surface defects; pharmacists should quarantine affected inventory and follow consignee notification instructions.

A nationwide recall of BioGlo Fluorescein Sodium Ophthalmic Strips USP has been issued following concerns over manufacturing quality. The product is packaged as 100 diagnostic strips per container and carries NDC 17238-900-11. It was manufactured by Omni Lens Pvt. Ltd, based in Ahmedabad, Gujarat, India, and manufactured for and distributed by HUB Pharmaceuticals, LLC, of Scottsdale, Arizona. A total of 184 320 containers are affected by the recall, which applies to all lots distributed in the US.

The recall, identified as Recall Number D-0352-2026 (event ID 98253), was initiated voluntarily by the firm on December 31, 2025. The FDA classified the action as a Class II recall on February 25, 2026. According to the Enforcement Report, the recalling firm is Wizcure Pharmaa Private Limited, located in Bhiwadi, India. The recall remains ongoing, and notification to consignees was conducted via letter. No press release has been issued for this action.

The reason for the recall is a lack of assurance of sterility, with the FDA noting that the products were not manufactured in conformance with CGMP. As a Class II recall, use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, with the probability of serious adverse health consequences considered remote. Fluorescein sodium ophthalmic strips are diagnostic agents used topically in the eye to aid in the detection of corneal abrasions, foreign bodies, and other ocular surface abnormalities during ophthalmic examinations.

Reference

FDA. Enforcement Report. February 25, 2026. Accessed February 26, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218211