Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is BUSPIRONE HYDROCHLORIDE recalled?

The FDA has recorded 9 recalls of BUSPIRONE HYDROCHLORIDE (2023–2026) , recalled under brand like BUSPIRONE HYDROCHLORIDE. 2 still ongoing.

0
Class I (most serious)
6
Class II
3
Class III
2
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of BUSPIRONE HYDROCHLORIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection. 5
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots 2
CGMP Deviations 1
Subpotent drug 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: P2105551, Exp. Date 7/31/2024;
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2200530, Exp. Date 12/31/2024; b) P2105583, Exp. Date 6/30/2024;
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indian Class II ongoing
Northwind Pharmaceuticals LLC 2023-03-16 lots: Lot#: F117312201, Exp. Date 06/30/2024
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: P2105472, Exp. Date 4/30/2024;
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024;
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: P2105483, Exp. Date 7/31/2024;
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, A Class III ongoing
Unichem Pharmaceuticals USA Inc. 2026-04-13 lots: Lot: ZBUL25001, Exp 12/31/2027
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 061 Class III Terminated
NCS Healthcare of Kentucky Inc 2023-10-27 lots: Lot#: a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card Class III Terminated
NCS Healthcare of Kentucky Inc 2023-10-27 lots: Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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