Class II · Moderate risk
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Is Olopatadine recalled?
Yes — there is an active recall. 10 ongoing FDA recalls mention Olopatadine (13 total). Check the affected lots below.
Most common reason: cGMP deviation (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Olopatadine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Olopatadine recalls on record
none so far in 2026; 13 on record, newest first
Class II · Moderate risk
Ryaltris (olopatadine hydrochloride and mometasone fluorate)
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Olopatadine HCl Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clear Eyes
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Olopatadine HCL Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Pataday
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Olopatadine 0.8% Ophthalmic Solution
Lack of Assurance of Sterility
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