CLASS III Drug recall · Reported 29 Nov 2023 · FDA Enforcement Report
Buspirone Hydrochloride Tabs USP 10 mg recalled
NCS Healthcare of Kentucky is recalling Buspirone Hydrochloride Tabs USP 10 mg, distributed nationwide in the US. The recall was initiated on 27 Oct 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0113-2024
- FDA event ID
- 93336
- Recalling firm
- NCS Healthcare of Kentucky, Glasgow, KY
- Manufacturer
- NCS HealthCare of KY, LLC dba Vangard Labs
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Oct 2023
- FDA classified
- 21 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Anxiety & Sleep Medication
Timeline
| 27 Oct 2023 | Recall initiated by company | |
| 21 Nov 2023 | Classified by FDA | +25 days |
| 29 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Which lots are affected?
Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93336This product is part of a recall event; the main page for the event is Lisinopril Tablets USP 20 mg recalled by NCS Healthcare of Kentucky.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Lisinopril Tablets USP 20 mg recalled by NCS Healthcare of KentuckyBuspirone Hydrochloride | NCS Healthcare of Kentucky | Packaging Defects | Nationwide |
More recalls from NCS Healthcare of Kentucky
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lisinopril Tablets USP 20 mg recalled by NCS Healthcare of KentuckyBuspirone Hydrochloride | NCS Healthcare of Kentucky | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Tabs, USP, 1 mg unit dose blister card recalled | NCS Healthcare of Kentucky | Potency & Assay | Nationwide |
Other Buspirone recalls
All 11| 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 III | Lisinopril Tablets USP 20 mg recalled by NCS Healthcare of KentuckyBuspirone Hydrochloride | NCS Healthcare of Kentucky | Packaging Defects | Nationwide |
| Drug | CLASS II | BusPIRone Hydrochloride Tablets USP, 7.5 mg recalledBuspirone Hydrochloride | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | BusPIRone Hydrochloride Tablets USP 15 mg recalled by Accord HealthcareBuspirone Hydrochloride | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | BusPIRone Hydrochloride Tablets USP 7.5 mg recalled by Accord HealthcareBuspirone Hydrochloride | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |