Ketotifen recalls
The FDA has published 2 recalls involving Ketotifen since 2022. The latest was reported on 24 May 2023. Most were for manufacturing (cgmp) deviations. RemedyRepack 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 recalls2since 2022
Last 12 months0reported
Class I00% of total
Ongoing1latest 24 May 2023
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why ketotifen is recalled
Companies
By year
Ongoing ketotifen recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketotifen Fumarate 0.025 %, Antihistamine eye drops, MFG recalled | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
All ketotifen recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketotifen Fumarate 0.025 %, Antihistamine eye drops, MFG recalled | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Systane Zaditor, ketotifen fumarate ophthalmic solution recalledZaditor | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
Should you stop taking Ketotifen?
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.