CLASS II Drug recall · Reported 26 Feb 2020 · FDA Enforcement Report
Glycopyrrolate Tabs, USP, 1 mg unit dose blister card recalled
NCS Healthcare of Kentucky is recalling Glycopyrrolate Tabs, USP, 1 mg unit dose blister card, For Institutional Use Only, distributed nationwide in the US. The recall was initiated on 28 Jan 2020 and the FDA has classified it as Class II.
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-0850-2020
- FDA event ID
- 84992
- Recalling firm
- NCS Healthcare of Kentucky, Glasgow, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2020
- FDA classified
- 18 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 Jan 2020 | Recall initiated by company | |
| 18 Feb 2020 | Classified by FDA | +21 days |
| 26 Feb 2020 | 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
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Which lots are affected?
Lot #: 8170-9004, Exp 01/2020
Where was it sold?
Nationwide in the 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from NCS Healthcare of Kentucky
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buspirone Hydrochloride Tabs USP 10 mg recalledBuspirone Hydrochloride | NCS Healthcare of Kentucky | Packaging Defects | Nationwide |
| Drug | CLASS III | Lisinopril Tablets USP 20 mg recalled by NCS Healthcare of KentuckyBuspirone Hydrochloride | NCS Healthcare of Kentucky | Packaging Defects | Nationwide |