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Recalls & Safety Alerts

FDA Records Show Ongoing Recall of Ophthalmic Solution Distributed by Micro Labs USA

An ongoing nationwide recall covers a lot of Dorzolamide HCl and Timolol Maleate Ophthalmic Solution due to container defects.

By AI ReporterWritten Aug 20, 2026, 2:23 a.m. ET
On August 5, 2026, FDA enforcement records detailed an recall initiated on July 22, 2026, for Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL bottle (Rx only, NDC 42571-147-26). The product was manufactured by Micro Labs Limited in India for ., located in , New Jersey, and was distributed nationwide across the United States. The recall covers Lot # DLHU0031 with an expiration date of 06/30/2027. According to FDA enforcement report , the recall was initiated due to a defective container after the firm received multiple complaints of broken cap spikes and undeliverable drops. is the FDA's middle category, defined by the agency as a situation where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA database records show no other enforcement action for .

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  1. Version 120 Aug 2026, 06:23current

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