Accord Healthcare, Inc. recalls Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord
Accord Healthcare recalls 25x2mL Glycopyrrolate injection vials due to label mix-up with 1mL vials. Correctly labeled vials were packaged into blister strips intended for 1mL vials.
Lower-risk recall
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Contact the company & request your remedy
What happened, in plain English
Accord Healthcare is recalling glycopyrrolate injection vials because they were incorrectly packaged with labels meant for 1mL vials instead of the actual 2mL vials. This mix-up could lead to incorrect dosing if the vials are used without checking the label carefully. Read more at govinfonow.com/recall/36540-accord-healthcare-glycopyrrolate-injection-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36540-accord-healthcare-glycopyrrolate-injection-recall-label-mix-up-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0250-2021
Cite this page
“Accord Healthcare Glycopyrrolate Injection Recall: Label Mix-Up Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36540-accord-healthcare-glycopyrrolate-injection-recall-label-mix-up-risk. Based on FDA recall #D-0250-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0250-2021%22&limit=1).
Why it’s dangerous
The vials are correctly labeled as 2mL but were packaged into blister strips designed for 1mL vials. This labeling error could cause confusion about the correct dosage if the vials are not checked carefully before use.
Who’s affected
Prescribers and healthcare facilities that use this injection for medical purposes. Patients receiving the medication under a doctor's supervision are most at risk if they use the vials without verifying the label.
How to tell if you have this one
Look for vials labeled 'Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only' with NDC 16729-472-08 (vial NDC 16729-472-30) manufactured by Intas Pharmaceuticals Limited, India.
- Brand
Accord Healthcare- Category
Drug
What to do — step by step
Check Label Carefully
Verify the vial label matches the actual 2mL size before use to avoid potential dosing errors.
Questions people ask
Why is this product being recalled?
The vials were correctly labeled as 2mL but were packaged into blister strips intended for 1mL vials, which could cause confusion about the correct dosage.
How can I tell if I have the recalled product?
Look for vials labeled 'Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only' with NDC 16729-472-08 (vial NDC 16729-472-30).
Do I need to stop using this product?
No, but you should check the label carefully before use to ensure you're using the correct dosage.
Contact Accord Healthcare
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0250-2021 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0250-2021 from Accord Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0250-2021 (January 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0250-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.