FDA drug recalls · openFDA

Is GLYCOPYRROLATE recalled?

The FDA has recorded 7 recalls of GLYCOPYRROLATE (2023–2025) , recalled under brand like GLYCOPYRROLATE. 1 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of GLYCOPYRROLATE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection. 4

Failed Impurities/Degradation Specifications 2

Labeling: Label Mix-up 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured fo Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: R2200259, Exp. Date 2/29/2024, R2200258, Exp. Date 2/29/2024, R2200617, Exp. Date 4/30/2024, R2201308, Exp. Date 8/31/2024

Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: R2200431, Exp. Date 7/31/2023, R2200439, Exp. Date 9/30/2023

Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured fo Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: R2200509, Exp. Date 4/30/2024, R2200507, Exp. Date 4/30/2024, R2200508, Exp. Date 4/30/2024

Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: R2200436, Exp. Date 1/31/2024, R2200159, Exp. Date 1/31/2024, R2200166, Exp. Date 1/31/2024, R2200618, Exp. Date 4/30/2024, R2201290, Exp. Date 8/31/2024, R2201324, Exp. Date 8/31/2024

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway Class III ongoing

NOVADOZ PHARMACEUTICALS LLC 2025-12-15 lots: Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027

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

HF Acquisition Co LLC 2023-06-06 lots: Lot #: 2205095.1, Exp. Date 7/31/2024

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, Class III Terminated

Aurolife Pharma, LLC 2023-05-18 lots: Lot #: 01421038A1, Exp. Date 05/2023

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

Machine-readable: JSON-LD · Markdown