AuroMedics Pharma recalls Glycopyrrolate injection vials with elevated benzaldehyde impurities. This may pose a risk to patients using the medication. Contact the manufacturer for details.
“AuroMedics Glycopyrrolate Injection Recall: Benzaldehyde Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37381-auromedics-glycopyrrolate-injection-recall-benzaldehyde-impurity-risk. Based on FDA recall #D-0853-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0853-2020%22&limit=1).
AuroMedics Pharma LLC voluntarily recalled Glycopyrrolate Injection USP due to elevated levels of Benzaldehyde impurity, according to a Food and Drug Administration announcement on Feb. 7, 2020.
How to tell if you have it
Brand: AuroMedics
Product: Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial
NDC: 55150-295-20
Lot: CGP190001-A
Expiration: 07/31/2020
Quantity: 4600 Vials
The hazard
The recall addresses failed impurities and degradation specifications, specifically the finding of elevated levels of Benzaldehyde impurity in investigative samples, according to the FDA.
Context
GovInfoNow's records show AuroMedics Pharma LLC has 22 other recalls on record since Dec. 4, 2017. Other recent recalls of similar products include Novadoz Glycopyrrolate Oral Solution Recall (Dec. 15, 2025), Somerset Therapeutics Dexamethasone Injection Recall (Feb. 4, 2026), and Lupin Ganirelix Acetate Injection Recall (Nov. 13, 2025).
How to tell if you have this one
Check for the product name 'Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial'. The lot number CGP190001-A and expiration date 07/31/2020 are also associated with this recall.
Brand
AuroMedics
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the product name and lot number CGP190001-A on the vial label.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “Ohio, Louisiana, Mississippi” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Louisiana, Mississippi, Ohio.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0853-2020 (February 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0853-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.