CLASS II Drug recall · Reported 24 Jul 2013 · FDA Enforcement Report
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL recalled
Fresenius Kabi USA is recalling Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, distributed nationwide in the US. The recall was initiated on 24 Jun 2013 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-804-2013
- FDA event ID
- 65512
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jun 2013
- FDA classified
- 17 Jul 2013
- Reported
- 24 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Jun 2013 | Recall initiated by company | |
| 17 Jul 2013 | Classified by FDA | +23 days |
| 24 Jul 2013 | 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
Subpotent Drug; 15-month stability test station
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
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use recalled?
Yes. Fresenius Kabi USA recalled Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use on 24 Jun 2013. The recall is Class II and its status is Terminated. Recall number D-804-2013.
Why was it recalled?
Subpotent Drug; 15-month stability test station
Which lots are affected?
Lot #: 6003648, Exp. 6/2013
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 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 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 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 Oxytocin recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxytocin for Injection, all strengths and presentations recalled | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS III | Pitocin (Oxytocin Injection, USP) Synthetic per mL recalledPitocin | JHP Pharmaceuticals | Packaging Defects | Nationwide |