Glycopyrrolate recalls

The FDA has published 43 recalls involving Glycopyrrolate since 2013. The latest was reported on 29 Jul 2026. Most were for sterility. Accord Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls43since 2013

Last 12 months3reported

Class I00% of total

Ongoing5latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 0Aug 0 0 0Nov 0 0 1Feb 0 0 0May 0 2 0Aug 0 0

Severity split

Class I 0 0%Class II 36 84%Class III 7 16%

Why glycopyrrolate is recalled

Companies

Brands

Glycopyrrolate1433%
Bevespi Aerosphere12%

By year

202637%
202512%
2023819%
2022614%
202149%
202025%
201925%
201812%
201737%
2016512%

Ongoing glycopyrrolate recalls

5 active

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate	Precision Dose	Potency & Assay	Nationwide
29 Jul 2026Drug	CLASS II	Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate	Fresenius Kabi USA	Particulate Matter	Nationwide
4 Feb 2026Drug	CLASS III	Glycopyrrolate Oral Solution, 1 mg recalled by Novadoz PharmaceuticalsGlycopyrrolate	Novadoz Pharmaceuticals	Potency & Assay	Nationwide
30 Apr 2025Drug	CLASS II	Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled	Denver Solutions	Sterility	Nationwide
28 Dec 2022Drug	CLASS II	Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate	Aurolife Pharma	Potency & Assay	Nationwide

All glycopyrrolate recalls, newest first

43 total

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate	Precision Dose	Potency & Assay	Nationwide
29 Jul 2026Drug	CLASS II	Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate	Fresenius Kabi USA	Particulate Matter	Nationwide
4 Feb 2026Drug	CLASS III	Glycopyrrolate Oral Solution, 1 mg recalled by Novadoz PharmaceuticalsGlycopyrrolate	Novadoz Pharmaceuticals	Potency & Assay	Nationwide
30 Apr 2025Drug	CLASS II	Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled	Denver Solutions	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	glycopyrrolate 1 mg/ (0.2 mg/mL), For Anesthesia Use, Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
28 Jun 2023Drug	CLASS III	Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate	Aurolife Pharma	Potency & Assay	Nationwide
14 Jun 2023Drug	CLASS III	Glycopyrrolate Injection, USP 0.2mg/ML Vial recalledGlycopyrrolate	HF Acquisition	Packaging Defects	AZ, CA, TX
8 Mar 2023Drug	CLASS II	Glycopyrrolate Injection, USP, 0.2 mg/mL Single Dose Vial x 25 vials recalledGlycopyrrolate	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Glycopyrrolate Injection, USP, 0.4 mg recalled by Accord HealthcareGlycopyrrolate	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Glycopyrrolate Injection, USP 4 mg recalled by Accord HealthcareGlycopyrrolate	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Glycopyrrolate Injection, USP 1 mg recalled by Accord HealthcareGlycopyrrolate	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
4 Jan 2023Drug	CLASS II	Glycopyrrolate Tablets, USP, 1 mg Unit Dose recalled by AVKAREGlycopyrrolate	Avkare	Potency & Assay	Nationwide
28 Dec 2022Drug	CLASS II	Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate	Aurolife Pharma	Potency & Assay	Nationwide
27 Jul 2022Drug	CLASS II	Glycopyrrolate Injection, USP, 1 mg/ (0.2 mg/mL) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Glycopyrrolate Injection, USP, 0.6 mg/ (0.2 mg/mL) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022Drug	CLASS II	Glycopyrrolate Injection, USP, 1 mg/ (0.2 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022Drug	CLASS II	Glycopyrrolate Injection, USP, 0.6 mg/ (0.2 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
6 Apr 2022Drug	CLASS II	Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate	Aurolife Pharma	Foreign Material	Nationwide
22 Sep 2021Drug	CLASS III	Glycopyrrolate Injection, USP 4mg per Multi-Dose Vials recalled	Meitheal Pharmaceuticals	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Bevespi Aerosphere (glycopyrrolate recalled by Cardinal HealthBevespi Aerosphere	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
17 Feb 2021Drug	CLASS III	Glycopyrrolate Injection, USP 0.4 mg/ (0.2 mg/mL) mL Single Dose recalledGlycopyrrolate	Accord Healthcare	Packaging Defects	Nationwide
13 Jan 2021Drug	CLASS II	Glycopyrrolate 1 mg/ (0.2mg/mL) Single Dose Syringe recalled	SCA Pharmaceuticals	Sterility	Nationwide
8 Apr 2020Drug	CLASS II	Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical	Par Pharmaceutical	Potency & Assay	NY
26 Feb 2020Drug	CLASS III	Glycopyrrolate Injection, USP 4 mg recalled by AuroMedics PharmaGlycopyrrolate	AuroMedics Pharma	Potency & Assay	LA, MS, OH
27 Mar 2019Drug	CLASS II	Glycopyrrolate 0.6 mg/ (0.2 mg per mL) Injectable Solution recalled	Advanced Pharma	Sterility	Nationwide
27 Mar 2019Drug	CLASS II	Glycopyrrolate Injectable Solution 1 mg/ (0.2 mg per mL) recalled	Advanced Pharma	Sterility	Nationwide
15 Aug 2018Drug	CLASS II	Glycopyrrolate 0.2 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
16 Aug 2017Drug	CLASS II	Glycopyrrolate Injection Solution 0.4 mg recalled by Cantrell Drug	Cantrell Drug	Sterility	Nationwide
16 Aug 2017Drug	CLASS II	Glycopyrrolate Injection Solution 0.2 mg recalled by Cantrell Drug	Cantrell Drug	Sterility	Nationwide
16 Aug 2017Drug	CLASS II	Glycopyrrolate Injection Solution 1 mg recalled by Cantrell Drug	Cantrell Drug	Sterility	Nationwide

Should you stop taking Glycopyrrolate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.