Meitheal Glycopyrrolate Injection Recall: Failed Impurities Risk
Meitheal Pharmaceuticals recalls 4mg per 20mL Glycopyrrolate Injection vials due to failed impurities and degradation. Affected lots expire Dec 2021-Apr 2022. Consumers should contact for details.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
Meitheal Pharmaceuticals is recalling 4mg per 20mL Glycopyrrolate Injection vials that may contain impurities or degrade. This could affect safety when used as prescribed by a doctor. Read more at govinfonow.com/recall/35864-meitheal-glycopyrrolate-injection-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35864-meitheal-glycopyrrolate-injection-recall-failed-impurities-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0801-2021
Cite this page
“Meitheal Glycopyrrolate Injection Recall: Failed Impurities Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35864-meitheal-glycopyrrolate-injection-recall-failed-impurities-risk. Based on FDA recall #D-0801-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0801-2021%22&limit=1).
Why it’s dangerous
The vials may have failed impurities or degradation specifications, which could lead to unsafe medication. This affects the drug's safety when used as intended by a healthcare provider.
Who’s affected
People with prescriptions for Glycopyrrolate Injection from Meitheal Pharmaceuticals in the US. Those using the medication for medical purposes are most at risk.
How to tell if you have this one
Check for vials labeled 'Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only'. Look for lot numbers G0010120 (exp. Dec 2021), G0080520 (exp. Apr 2022), G0090221 or G0100221 (exp. Jan 2023).
- Brand
Meitheal Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Details
Look for lot numbers G0010120 (exp. Dec 2021), G0080520 (exp. Apr 2022), G0090221 or G0100221 (exp. Jan 2023) on the vial.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide within the USA and India” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0801-2021 (September 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0801-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.