CLASS III Drug recall · Reported 19 Aug 2015 · FDA Enforcement Report
Hydralazine Hydrochloride Injection, USP, 20 mg/mL fill recalled
Fresenius Kabi USA is recalling Hydralazine Hydrochloride Injection, USP, 20 mg/mL fill, in a; single dose vial, distributed nationwide in the US. The recall was initiated on 28 Jul 2015 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-1327-2015
- FDA event ID
- 71827
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jul 2015
- FDA classified
- 12 Aug 2015
- Reported
- 19 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 28 Jul 2015 | Recall initiated by company | |
| 12 Aug 2015 | Classified by FDA | +15 days |
| 19 Aug 2015 | 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
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Which lots are affected?
Lot #: 6110593, Exp 11/2016
Where was it sold?
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 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.
More recalls from Fresenius Kabi USA
All 94| 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 Hydralazine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HydrALAZINE Hydrochloride recalled by Sky Packaging | SKY Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | HydrALAZINE Hydrochloride , USP, 50mg recalled by Sky Packaging | SKY Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Hydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug Group | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | HydrALAZINE Hydrochloride Tablets, USP 10mg recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS III | HydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 x per unit dose recalled | Amerisource Health Services | Potency & Assay | Nationwide |