Class III · Low risk
busPIRone Hydrochloride Tablets
Subpotent drug
Is Buspirone recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Buspirone (10 total). Check the affected lots below.
Most common reason: cGMP deviation (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Buspirone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Buspirone recalls in 2026
1 initiated in 2026, 10 in total — newest first
Class III · Low risk
Buspirone Hydrochloride Tabs USP 10 mg
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 30 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 15 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 7.5 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
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