Glycopyrrolate recalls

The FDA has published 28 recalls involving Glycopyrrolate since 2013. The latest was reported on 29 Jul 2026. Most were for potency & assay. 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 recalls28since 2013

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 21 75%Class III 7 25%

Why glycopyrrolate is recalled

Companies

Brands

Glycopyrrolate1450%
Bevespi Aerosphere14%

By year

2026311%
2023725%
2022621%
2021311%
202027%
2017311%
201527%
201414%
201314%

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

28 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

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.