Glycopyrrolate injectable syringes recalled nationwide for sterility assurance failure
Denver Solutions (Leiters Health) is recalling 170 Glycopyrrolate 1mg/5mL single-dose syringes nationwide due to leaking and damaged units compromising 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: This is an FDA Class II recall with no reported hospitalizations or illnesses. However, the hazard—compromised sterility in an injectable medication due to leaking or damaged syringes—represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for Score 3 (High).
Plain-English summary
Denver Solutions, LLC (Leiters Health) is recalling Glycopyrrolate 1mg per 5mL single-dose 5mL syringes. The recalled product is lot #2431015B with an expiration date of 4/10/2025. Approximately 170 syringes were distributed nationwide.
The recall was initiated due to lack of assurance of sterility. Some syringes in the lot are leaking or damaged, which compromises the sterile integrity of this injectable medication.
This is an FDA Class II recall (recall number D-0370-2025). Healthcare providers and patients who have this product should be aware of the recall situation.
The recalled product
- Product
- Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Injectable / Parenteral
- Hazard
- sterility-failure
- contamination-risk
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 #: 2431015B
- Exp. 4/10/2025.
Distribution
Distributed nationwide across the United States.
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