AuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity
AuroMedics Pharma LLC is recalling 4,600 vials of Glycopyrrolate Injection due to elevated levels of Benzaldehyde impurity found in investigative samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences, and no illnesses or injuries are reported in the source text.
Plain-English summary
AuroMedics Pharma LLC is recalling 4,600 vials of Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial. The product is identified by NDC 55150-295-20, Lot #CGP190001-A, and an expiration date of 07/31/2020. The recall was initiated because elevated levels of Benzaldehyde impurity were found in investigative samples (retain samples).
The affected product was distributed in Ohio, Louisiana, and Mississippi. The medication is a prescription-only drug intended for intramuscular or intravenous use and is not for use in newborns. It contains Benzyl Alcohol and was made in India.
Healthcare providers and patients should stop using the affected product and contact AuroMedics Pharma LLC for further instructions or a replacement.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 4,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #CGP190001-A
- Exp. 07/31/2020
UPCs (1)
- 0355150295203
Distribution
Related recalls
Same brand · GLYCOPYRROLATE
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate oral solution recalled after failing impurity and degradation specifications
FDA (Drugs) · 2026-02-04
- ModerateGlycopyrrolate Tablets Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2023-06-28
- ModerateGlycopyrrolate Injection Vials Recalled Due to Labeling Mix-up
FDA (Drugs) · 2023-06-14
Same manufacturer · AuroMedics Pharma LLC
See all →- HighFondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation
FDA (Drugs) · 2022-11-02
- HighAcyclovir Sodium Injectable Recalled for Particulate Matter
FDA (Drugs) · 2022-10-26
- LowTranexamic Acid Injection Recalled for Metal Particulate Matter
FDA (Drugs) · 2022-10-12
- SeverePolymyxin B for Injection Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2022-02-16
- SevereAuroMedics Recalls Acetaminophen Injection Due to Discoloration and pH Failures
FDA (Drugs) · 2021-02-10
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17