CLASS II ONGOING Drug recall · Reported 30 Apr 2025 · FDA Enforcement Report
Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled
Denver Solutions is recalling Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe, distributed nationwide in the US. The recall was initiated on 31 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0373-2025
- FDA event ID
- 96607
- Recalling firm
- Denver Solutions, Englewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Mar 2025
- FDA classified
- 18 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 31 Mar 2025 | Recall initiated by company | |
| 18 Apr 2025 | Classified by FDA | +18 days |
| 30 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Leaking/damaged syringes.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the U.S.A
Questions about this recall
Is Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled?
Yes. Denver Solutions recalled Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe on 31 Mar 2025. The recall is Class II and its status is Ongoing. Recall number D-0373-2025.
Why was it recalled?
Lack of Assurance of Sterility: Leaking/damaged syringes.
Which lots are affected?
Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.
Where was it sold?
Nationwide in the U.S.A
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Denver Solutions
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PHENYLephrine HCl in 9% Sodium Chloride, 5 mg recalled | Denver Solutions | Foreign Material | Nationwide |
| Drug | CLASS II | Glycopyrrolate, 1mg per, 2 mg/mL), Single Dose syringe recalled | Denver Solutions | Foreign Material | Nationwide |
| Drug | CLASS II | dexmedeTOMIDine HCl PF, in 9% Sodium Chloride, 20 mcg recalled | Denver Solutions | Foreign Material | Nationwide |
| Drug | CLASS II | Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled | Denver Solutions | Foreign Material | Nationwide |
| Drug | CLASS II | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution recalled | Denver Solutions | Particulate Matter | Nationwide |