CLASS II ONGOING Drug recall · Reported 18 Feb 2026 · FDA Enforcement Report
ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalled
Fresenius Kabi Compounding is recalling ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) in Sodium Chloride Injection, Fagron, distributed nationwide in the US. The recall was initiated on 5 Feb 2026 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-0334-2026
- FDA event ID
- 98391
- Recalling firm
- Fresenius Kabi Compounding, Canton, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Feb 2026
- FDA classified
- 13 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Feb 2026 | Recall initiated by company | |
| 13 Feb 2026 | Classified by FDA | +8 days |
| 18 Feb 2026 | Published in enforcement report | +5 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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 31-Mar-26; Lot # C274-000049119, Exp Date: 19-Apr-26; Lot # C274-000049282, Exp Date: 27-Apr-26
Where was it sold?
US Nationwide.
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 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
4 other products · FDA event 98391This product is part of a recall event; the main page for the event is thiamine HCl, 500 mg, 500 mg added recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | thiamine HCl, 500 mg, 500 mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide | |
| CLASS II | vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Sterility | Nationwide | |
| CLASS II | vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Sterility | Nationwide | |
| CLASS II | acyclovir sodium, 200 mg, 200mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
More recalls from Fresenius Kabi Compounding
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | acyclovir sodium, 200 mg, 200mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | thiamine HCl, 500 mg, 500 mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Manufacturing (CGMP) Deviations | Nationwide |
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 III | Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled | Staq Pharma | Other | 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 |