Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Glycopyrrolate Injection Recalled by AuroMedics Pharma LLC Due to Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity...

Date: February 7, 2020
Company: AuroMedics Pharma LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AuroMedics Pharma LLC directly.

Affected Products

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.

Quantity: 4600 Vials

Why Was This Recalled?

Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).

Where Was This Sold?

Ohio, Louisiana, Mississippi

About AuroMedics Pharma LLC

AuroMedics Pharma LLC has 36 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report