Glycopyrrolate Injection

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

Cause type: Impurity / degradation

An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.

What was recalled

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.

Affected NDC 55150-0295-20

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Glycopyrrolate NDC 55150-0295	.2 mg/mL	Injection, Solution Intramuscular\|intravenous	AuroMedics Pharma LLC	Rx

Recalling firm: AuroMedics Pharma LLC
NDC code: 55150-295-20
Origin: NJ, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0853-2020 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.