Azelastine hydrochloride nasal recalls
The FDA has published 2 recalls involving Azelastine hydrochloride nasal since 2017. The latest was reported on 7 Jun 2023. Most were for potency & assay. Roxane Laboratories 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 2017
Last 12 months0reported
Class I00% of total
Ongoing1latest 7 Jun 2023
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 1 50%Class III 1 50%
Why azelastine hydrochloride nasal is recalled
Companies
By year
Ongoing azelastine hydrochloride nasal recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelastine Hydrochloride Nasal Spray, 15%, 105.5 mcg per spray recalled | Akorn | Potency & Assay | Nationwide |
All azelastine hydrochloride nasal recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelastine Hydrochloride Nasal Spray, 15%, 105.5 mcg per spray recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Azelastine Hydrochloride Nasal Solution (Nasal Spray) recalled | Roxane Laboratories | Potency & Assay | Nationwide |
Should you stop taking Azelastine hydrochloride nasal?
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.