CLASS II Drug recall · Reported 8 Feb 2017 · FDA Enforcement Report
Midazolam Injection, USP, *25 mg/, (5 mg/ mL) vials, 10 Vials recalled
Fresenius Kabi USA is recalling Midazolam Injection, USP, *25 mg/, (5 mg/ mL) vials, 10 Vials per, distributed nationwide in the US. The recall was initiated on 16 Dec 2016 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-0456-2017
- FDA event ID
- 76001
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Brand
- Midazolam
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2016
- FDA classified
- 2 Feb 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Dec 2016 | Recall initiated by company | |
| 2 Feb 2017 | Classified by FDA | +48 days |
| 8 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Where was it sold?
Nationwide and Puerto Rico
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.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Midazolam recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Midazolam HCl 100 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS I | Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | midazolam in dextrose 5%, 50 mg/, (1 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | midazolam in dextrose 5%, 50 mg /, (1 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |