Glycopyrrolate Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 3450 glycopyrrolate injection syringes (NDC 69374-903-30, Lot GL2004A) nationwide due to lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for lack of sterility assurance in an injectable medication. No reported illnesses or injuries are mentioned in the source text, making this a theoretical risk-of-harm situation.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 3450 pre-filled glycopyrrolate injection syringes due to lack of assurance of sterility. The affected product is Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), NDC 69374-903-30, Lot GL2004A, expiration date August 26, 2022. The product was distributed nationwide.
When injectable medications cannot be assured to be sterile, there is a risk of bacterial contamination. If a non-sterile injection is administered to a patient, it could introduce pathogenic organisms into the body, potentially causing serious infections.
If you have received this product, contact your healthcare provider or pharmacy for guidance. Do not use the recalled syringes.
The recalled product
- Product
- Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-30
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable / Parenteral
- Affected units
- 3,450
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: GL2004A
- Exp. 8/26/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 37 recalled by Nephron Sterile Compounding Center LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 37 products in this recall →Related recalls
Same manufacturer · Nephron Sterile Compounding Center LLC
See all →- HighSodium Chloride Injection Recalled for Potential Sterility Compromise
FDA (Drugs) · 2025-03-19
- HighNorepinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighNephron Phenylephrine HCl Injection Recalled for Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighDiltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-03-08
- HighFDA Recalls Norepinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2023-03-08
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08