Glycopyrrolate Injection Recalled Due to Manufacturing Quality Deviations
Accord Healthcare is recalling Glycopyrrolate Injection (4 mg/20 mL) from two batches due to CGMP deviations identified during FDA inspection. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall due to manufacturing quality deviations (CGMP) identified during regulatory inspection. No illnesses or injuries have been reported; the hazard relates to potential quality and safety risks from manufacturing defects.
Plain-English summary
Accord Healthcare, Inc. is recalling Glycopyrrolate Injection, USP (4 mg/20 mL, 0.2 mg/mL) across the United States, Puerto Rico, and Canada. The recall affects 322 vials from two batches: R2200431 (expiration 7/31/2023) and R2200439 (expiration 9/30/2023). The product is manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India.
The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. CGMP standards ensure drugs are manufactured under safe, quality conditions. No illnesses or injuries related to this product have been reported.
If you have received this product, do not use it. Patients and healthcare providers should consult with a pharmacist or healthcare provider about alternative treatments. This product may not meet established quality standards due to the identified manufacturing deviations.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 322
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Batches: R2200431
- Exp. Date 7/31/2023
- R2200439
- Exp. Date 9/30/2023
UPCs (6)
- 0316729474054
- 0316729472302
- 0316729473316
- 0316729471633
- 316729474054
- 316729474030
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 67 products in this recall →Related recalls
Same brand · GLYCOPYRROLATE
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate oral solution recalled after failing impurity and degradation specifications
FDA (Drugs) · 2026-02-04
- ModerateGlycopyrrolate Tablets Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2023-06-28
- ModerateGlycopyrrolate Injection Vials Recalled Due to Labeling Mix-up
FDA (Drugs) · 2023-06-14
Same manufacturer · Accord Healthcare, Inc.
See all →- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- LowAccord Recalls Glycopyrrolate Injection Due to Labeling Mix-up
FDA (Drugs) · 2021-02-17
- ModerateGlimepiride Tablets Recall Due to Manufacturing Quality Deviations
FDA (Drugs) · 2023-04-12
- ModerateGlycopyrrolate Injection Vials Recalled Due to Labeling Mix-up
FDA (Drugs) · 2023-06-14
- ModerateGlycopyrrolate Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-09-22
- ModerateAuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity
FDA (Drugs) · 2020-02-26
- ModerateGlimepiride Tablets Recalled Due to Manufacturing Process Deviations
FDA (Drugs) · 2023-04-12