Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk
FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class III recall for potential medication contamination—foreign Amlodipine tablets may be present in Buspirone shipments. While no illnesses have been reported and the contamination is unconfirmed, the potential for serious harm is significant: patients could unknowingly receive an incorrect medication.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling certain lots of Buspirone Hydrochloride 10 mg tablets distributed nationwide due to the potential presence of foreign tablets of Amlodipine Besylate 10 mg within the recalled shipments. The recall affects 1,344 blister cards manufactured by NCS Healthcare of Kentucky Inc, with lot number 7718-3008 (expiration date: August 31, 2024).
Buspirone is a prescription anti-anxiety medication, while Amlodipine Besylate is a blood pressure medication. If patients received tablets from the contaminated lots, they could unknowingly consume a different medication than prescribed, which could result in loss of intended treatment and potential adverse effects from an unintended medication.
The contaminated product was identified by its National Drug Codes (NDC): 0615-7718-05 (15-count blister card) and 0615-7718-39 (30-count blister card). Patients with prescriptions filled from lot 7718-3008 should verify their medication immediately.
The recalled product
- Product
- BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
- Brand
- BUSPIRONE HYDROCHLORIDE
- Manufacturer
- NCS Healthcare of Kentucky Inc
- Category
- Drug — Prescription Drug
- Hazard
- medication-contamination
- wrong-medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot#: a) 7718-3008
- Exp 08/31/2024
- b) 7718-3008
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · BUSPIRONE HYDROCHLORIDE
- LowBuspirone Hydrochloride Tablets 5 mg Recalled for Subpotency
FDA (Drugs) · 2026-05-13
- ModerateLisinopril Tablets Recalled for Stray Amlodipine Tablet Contamination
FDA (Drugs) · 2023-11-29
- ModerateDrug Recall: Buspirone Tablets Over Manufacturing Process Deviations
FDA (Drugs) · 2023-05-03
- HighFDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- HighFDA Recalls Accord Healthcare Buspirone 15 mg Tablets for Manufacturing Deviations
FDA (Drugs) · 2023-03-08
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08