Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Is Dorzolamide recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Dorzolamide (6 total). Check the affected lots below.
Most common reason: Chemical / undeclared (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dorzolamide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Dorzolamide recalls in 2026
1 initiated in 2026, 6 in total — newest first
Class II · Moderate risk
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Timolol- Dorzolamide- Latanoprost P-F
Subpotent Drug
Class III · Low risk
COSOPT Ophthalmic Solution
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class II · Moderate risk
Timolol-Brimonidine-Dorzolamide-Latanoprost
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
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