Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Glycopyrrolate

Brand names: Glyrx-Pf, Glycate, Cuvposa

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
To be discontinuedFDA shortage list
14Recalls (FDA reports)
60Companies
1961First FDA approval on file

Quick answers

What is Glycopyrrolate used for?
The FDA-approved label (Glyrx-Pf, Exela Pharma Sciences, LLC, July 23, 2025) says: “GLYRX ® -PF is indicated: in anesthesia (all ages) • for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, • intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and • for protection against peripheral …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Glycopyrrolate have a boxed warning?
No. None of the 110 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Glycopyrrolate?
The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated July 30, 2026). Ask your pharmacist about alternatives.
Has Glycopyrrolate been recalled?
FDA enforcement reports list 14 recalls of products of this medicine; the newest started July 16, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Glycopyrrolate?
60 companies list prescription products of Glycopyrrolate in the FDA NDC Directory, including Medical Purchasing Solutions, LLC, Bryant Ranch Prepack and Hikma Pharmaceuticals USA Inc..

What Glycopyrrolate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

GLYRX ® -PF is indicated: in anesthesia (all ages) • for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, • intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and • for protection against peripheral …

— FDA label: Glyrx-Pf, Exela Pharma Sciences, LLC, effective July 23, 2025. Read the full label on DailyMed →

The FDA has 110 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 110 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection · Tablet · Injection, solution · Solution · Liquid
RouteIntramuscular · Intravenous · Oral
Prescription products190 in the FDA NDC Directory
Brand namesGlyrx-Pf, Glycate, Cuvposa

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Glycopyrrolate, by strength and form
Strength and formGeneric or brandPharmacies pay
glycopyrrolate 0.2 mg/mL
injection		 Generic $1.58 per mL
glycopyrrolate 0.2 mg/mL
injection, solution		 Generic $1.58 per mL
glycopyrrolate 0.2 mg/mL
solution		 Generic $1.58 per mL
glycopyrrolate 1 mg
tablet		 Generic $0.0987 per tablet
glycopyrrolate 1 mg/5 mL
liquid		 Generic $0.1926 per mL
glycopyrrolate 1 mg/5 mL
liquid		 Brand: Cuvposa $1.01 per mL
glycopyrrolate 1 mg/5 mL
solution		 Generic $0.1926 per mL
glycopyrrolate 2 mg
tablet		 Generic $0.1545 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA012827
ROBINUL, ROBINUL FORTE		 Casper Pharma LLCAugust 11, 1961 41, latest September 27, 2022
2022: Labeling · 2015: Manufacturing (CMC) · 2003: Manufacturing (CMC)
NDA017558
ROBINUL		 HikmaFebruary 6, 1975 44, latest February 24, 2026
2026: Labeling · 2025: Manufacturing (CMC) · 2025: Efficacy
NDA022571
CUVPOSA		 Merz PharmsJuly 28, 2010 6, latest February 23, 2018
2018: Labeling · 2016: Labeling · 2016: Manufacturing (CMC)
NDA210997
GLYRX-PF		 Exela PharmaJuly 11, 2018 1, latest July 16, 2025
2025: Efficacy
NDA214919
GLYCOPYRROLATE		 Fresenius Kabi USAApril 21, 2022 1, latest July 16, 2025
2025: Efficacy

Generic approvals (40)

Shortage status

To be discontinued · updated July 30, 2026 · first posted July 30, 2026

ProductGlycopyrrolate, Injection, 0.2 mg per 1 mL (NDC 65219-801-01)
CompanyFresenius Kabi USA, LLC

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. July 16, 2026 · Class II · Ongoing · D-0725-2026

    Presence of Particulate Matter: Hair was found in product

    Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07 — Fresenius Kabi USA, LLC

  2. July 14, 2026 · Class II · Ongoing · D-0741-2026

    Failed Impurities/Degradation Specifications

    Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case). — Precision Dose Inc.

  3. December 15, 2025 · Class III · Ongoing · D-0300-2026

    Failed Impurities/Degradation Specifications

    Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 — NOVADOZ PHARMACEUTICALS LLC

  4. June 6, 2023 · Class III · Terminated · D-0870-2023

    Labeling: Label Mix-up

    GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3 — HF Acquisition Co LLC

  5. May 18, 2023 · Class III · Terminated · D-0877-2023

    Failed Impurities/Degradation Specifications

    Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 — Aurolife Pharma, LLC

  6. February 7, 2023 · Class II · Terminated · D-0398-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ph — Accord Healthcare, Inc.

  7. February 7, 2023 · Class II · Terminated · D-0396-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 — Accord Healthcare, Inc.

  8. February 7, 2023 · Class II · Terminated · D-0397-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ph — Accord Healthcare, Inc.

  9. February 7, 2023 · Class II · Terminated · D-0399-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Phar — Accord Healthcare, Inc.

  10. December 22, 2022 · Class II · Completed · D-0091-2023

    Failed impurities/degradation specifications: Out of specification for unknown impurities.

    Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15 — AVKARE LLC

  11. December 16, 2022 · Class II · Ongoing · D-0087-2023

    Failed Impurities/Degradation Specifications

    Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 — Aurolife Pharma, LLC

  12. March 17, 2022 · Class II · Terminated · D-0736-2022

    Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.

    Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01. — Aurolife Pharma, LLC

  13. January 28, 2021 · Class III · Terminated · D-0250-2021

    Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

    Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 21 — Accord Healthcare, Inc.

  14. February 7, 2020 · Class III · Terminated · D-0853-2020

    Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).

    Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, — AuroMedics Pharma LLC

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)197738, 197739, 238212, 999961, 999965, 1247658, 1437975, 1731582, 1731590, 2101490 … (+7)
SPL set ID of the quoted label2189f3f5-39dc-4e85-b7c6-9515ded59686
FDA labels (SPL)110
FDA applicationsNDA012827, NDA017558, NDA022571, NDA210997, NDA214919, 40 ANDA
Active ingredients (FDA)GLYCOPYRROLATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Glyrx-Pf, Exela Pharma Sciences, LLC, effective July 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers