Ketamine HCl Syringes Recalled for Lack of Sterility Assurance
Denver Solutions, LLC is recalling Ketamine HCl 50mg per 5mL single-dose syringes nationwide due to leaking or damaged syringes that may lack sterility assurance. Two affected lots are identified with expiration dates in July 2025.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug product with a significant safety hazard (loss of sterility assurance due to leaking/damaged containers). Per the rubric, Class II recalls with risk of serious health consequences—such as infection from non-sterile injectable medications—are classified as Severe (score 4).
Plain-English summary
Denver Solutions, LLC DBA Leiters Health is recalling Ketamine HCl 50mg per 5mL single-dose syringes (NDC 71449-068-11) distributed nationwide in the United States because some syringes are leaking or damaged, which compromises assurance of sterility.
The affected product includes two lots: Lot #2530019 (expiration 7/10/2025) and Lot #2530053 (expiration 7/19/2025). A total of 49,830 syringes are affected by this recall.
Patients and healthcare providers who have received this product should not use affected syringes and should contact their pharmacy or healthcare provider for guidance on replacement. Sterile injectable medications that are leaking or damaged may pose a risk of infection if administered.
The recalled product
- Product
- Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Affected units
- 49,830
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 (4)
- Lot #:2530019
- Exp.: 7/10/2025
- 2530053
- Exp.: 7/19/2025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Denver Solutions, LLC DBA Leiters Health 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.
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