Class III · Low risk
COSOPT Ophthalmic Solution
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Is Timolol recalled?
Yes — there is an active recall. 14 ongoing FDA recalls mention Timolol (34 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Timolol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Timolol recalls on record
none so far in 2026; 34 on record, newest first
Class III · Low risk
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution)
Failed Impurities/Degradation Specifications.
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
Timolol-Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
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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