CLASS III ONGOING Drug recall · Reported 22 Oct 2025 · FDA Enforcement Report
Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled
Staq Pharma is recalling Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection for IV use syringe, STAQ Pharma Inc, distributed nationwide in the US. The recall was initiated on 9 Oct 2025 and the FDA has classified it as Class III.
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-0024-2026
- FDA event ID
- 97779
- Recalling firm
- Staq Pharma, Denver, CO
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 9 Oct 2025
- FDA classified
- 15 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Oct 2025 | Recall initiated by company | |
| 15 Oct 2025 | Classified by FDA | +6 days |
| 22 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Product as listed by the FDA
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which lots are affected?
Lot #: 25156673A, Expiry: 02FEB2026.
Where was it sold?
Nationwide in the U.S.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97779| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Hydromorphone HCL PF, 10mg/ (0.2mg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide | |
| CLASS III | FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
More recalls from Staq Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
| Drug | CLASS III | Hydromorphone HCL PF, 10mg/ (0.2mg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
| Drug | CLASS II | ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg recalled | Staq Pharma | Packaging Defects | Nationwide |
| Drug | CLASS I | Morphine Sulfate PF 25 mg/ (1 mg/mL) in NaCl in Single Dose Syringe recalled | Staq Pharma | Labeling Errors | CO, OH, TX |
| Drug | CLASS I | HYDROmorphone HCl PF 10 mg/ (0.2mg/mL) in NaCl recalled by STAQ Pharma | Staq Pharma | Labeling Errors | CO, OH, TX |
Other Ketamine recalls
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketamine Hydrochloride Injectable Solution, 50mg/ml recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | KETAmine Hydrochloride Injection, USP, 500mg/, (10mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | KETAmine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) recalled | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | ketamine in 0.9% sodium chloride, 50 mg/ (10mg/mL) syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |