FDA Drug Recalls

Recalls / Active ingredient / Glycopyrrolate

Glycopyrrolate

13 FDA drug recalls involving the active ingredient “Glycopyrrolate”.

DateClassProductFirm
2025-12-15Class IIIGlycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., NOVADOZ PHARMACEUTICALS LLC
2023-06-06Class IIIGLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, HF Acquisition Co LLC
2023-05-18Class IIIGlycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., EasAurolife Pharma, LLC
2023-02-07Class IIGlycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Accord Healthcare, Inc.
2023-02-07Class IIGlycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, ManufAccord Healthcare, Inc.
2023-02-07Class IIGlycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, ManufAccord Healthcare, Inc.
2023-02-07Class IIGlycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, ManufacAccord Healthcare, Inc.
2022-12-22Class IIGlycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE PulasAVKARE LLC
2022-12-16Class IIGlycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East WindAurolife Pharma, LLC
2022-03-17Class IIGlycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Aurolife Pharma, LLC
2021-03-15Class IIBevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation FoCardinal Health Inc.
2021-01-28Class IIIGlycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: AAccord Healthcare, Inc.
2020-02-07Class IIIGlycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For IntramuscularAuroMedics Pharma LLC