Buspirone recalls
The FDA has published 11 recalls involving Buspirone since 2020. The latest was reported on 13 May 2026. Most were for manufacturing (cgmp) deviations. Accord Healthcare 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 recalls11since 2020
Last 12 months1reported
Class I00% of total
Ongoing2latest 13 May 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 8 73%Class III 3 27%
Why buspirone is recalled
Companies
By year
Ongoing buspirone recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | busPIRone Hydrochloride Tablets, USP, 5 mg recalledBuspirone Hydrochloride | Unichem Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | BusPIRone Hydrochloride Tablets USP, 5 mg recalledBuspirone Hydrochloride | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
All buspirone recalls, newest first
11 totalShould you stop taking Buspirone?
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.