Drug & Device Safety Atlas
Class III FDA drug recall · D-0114-2024

Class III — the FDA judged the product is unlikely to cause harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.

Why it was recalled

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

The recall was initiated by NCS Healthcare of Kentucky Inc (the firm that distributes or relabels it); the product is made by NCS HealthCare of KY, LLC dba Vangard Labs. That is normal — the distributor, not always the maker, files the recall.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information
Lot#: a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024

Recall status

Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.

Where it was distributed

Nationwide USA

Recall record

Recalling firm
NCS Healthcare of Kentucky Inc
Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Brand name
BUSPIRONE HYDROCHLORIDE
Generic name
BUSPIRONE HYDROCHLORIDE
Product type
Drugs
Recall number
D-0114-2024
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Glasgow, KY
Recall initiated
2023-10-27
Terminated
2024-07-14

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall D-0114-2024 · Source: openFDA enforcement.