Glycopyrrolate recalls

Glycopyrrolate products have been recalled 14 times, most recently on 29 Jul 2026. The recalling company is usually Accord Healthcare. The most common reason is potency & assay.

Total recalls14since 2020

Last 12 months3reported

Class I00% of total

Ongoing4latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 1 0 0Apr 0 0 2Jul 0 0

Severity split

Class I 0 0%Class II 9 64%Class III 5 36%

Why glycopyrrolate is recalled

Companies

Product types

Injectable & IV Drugs857%

By year

2026321%
2023750%
2022214%
202117%
202017%

Ongoing glycopyrrolate recalls

4 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 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
28 Dec 2022Drug	CLASS II	Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate	Aurolife Pharma	Potency & Assay	Nationwide

All glycopyrrolate recalls, newest first

14 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 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
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 2mg/ML Vial recalled by HF Acquisition CoGlycopyrrolate	HF Acquisition Co	Packaging Defects	AZ, CA, TX
8 Mar 2023Drug	CLASS II	Glycopyrrolate Injection, USP, 2 mg/mL Single Dose Vial x 25 vials recalledGlycopyrrolate	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Glycopyrrolate Injection recalled by Accord HealthcareGlycopyrrolate	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Glycopyrrolate Injection, USP 4 mg/ 2 mg/mL) Multiple Dose recalledGlycopyrrolate	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Glycopyrrolate Injection, USP 1 mg/ 2 mg/mL) Multiple Dose recalledGlycopyrrolate	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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.