Olopatadine recalls
The FDA has published 12 recalls involving Olopatadine since 2016. The latest was reported on 29 Oct 2025. Most were for manufacturing (cgmp) deviations. Akorn has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls12since 2016
Last 12 months1reported
Class I00% of total
Ongoing10latest 29 Oct 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 12 100%Class III 0 0%
Why olopatadine is recalled
Companies
Brands
By year
Ongoing olopatadine recalls
10 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recalled | USV Private | Potency & Assay | Nationwide |
| Drug | CLASS II | Ryaltris (olopatadine hydrochloride recalled by Glenmark PharmaceuticalsRyaltris | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS II | Olopatadine HCl Nasal Spray, 665 mcg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
All olopatadine recalls, newest first
12 totalShould you stop taking Olopatadine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.