Glycopyrrolate Injection (AuroMedics) – Benzaldehyde Impurity (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.
Brand
AuroMedics Pharma LLC
Lot Codes / Batch Numbers
Lot #CGP190001-A, Exp. 07/31/2020
Products Sold
Lot #CGP190001-A, Exp. 07/31/2020
AuroMedics Pharma LLC is recalling Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Int due to Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
LA, MS, OH
Page updated: Jan 7, 2026