Dorzolamide and Timolol Ophthalmic Solution Recalled Due to Defective Containers

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for dorzolamide and timolol maleate ophthalmic solution, 10 mL. The affected batch has been identified as Lot DLHU0031 (expiration June 2027).
• The recall was initiated by Micro Labs USA, Inc due to defective containers, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Dorzolamide plus timolol is used to treat glaucoma and ocular hypertension.

The FDA has issued a Class II recall for dorzolamide and timolol maleate ophthalmic solution, 10 mL. This product is being recalled by Micro Labs USA, Inc based in Somerset, New Jersey. The recall was initiated on July 22, 2026, and received a Class II classification on July 24, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after the firm received complaints about defective containers, which had broken cap spikes and undeliverable drops. This deficiency affects Lot DLHU0031, which will expire in June 2027. Micro Labs USA sent out a public notice via letter; no press release has been issued for this recall.

Dorzolamide plus timolol is a prescription medication used to treat glaucoma and ocular hypertension by lowering pressure in the eye. Pharmacists should identify and quarantine Lot DLHU0031, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 5, 2026. Accessed August 5, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221668