Ketamine Syringes Recalled for Leaking and Sterility Assurance Failures
Leiters Health is recalling 49,830 ketamine HCl syringes nationwide due to leaking and damaged units that compromise sterility assurance. Affected patients should contact their healthcare provider.
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 due to lack of sterility assurance in injectable ketamine syringes caused by leaking and damaged equipment. No illnesses or injuries have been reported. While lack of sterility in injectable products poses a significant contamination risk, the absence of reported harm and the Class II classification place this at High severity.
Plain-English summary
Leiters Health (Denver Solutions, LLC), located in Englewood, Colorado, is recalling 49,830 ketamine HCl 50 mg per 5 mL single-dose syringes (NDC 71449-068-11) distributed nationwide. The recall is due to a lack of assurance of sterility resulting from leaking and damaged syringes.
The affected lots are Lot #2530019 (expiring 7/10/2025) and Lot #2530053 (expiring 7/19/2025).
Healthcare providers and pharmacists should stop dispensing the affected product immediately. Patients who received syringes from these lots should contact their healthcare provider or pharmacist to discuss their treatment and any questions about the affected medication.
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
- Hazard
- lack-of-sterility
- leaking-syringe
- damaged-syringe
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27