CLASS II Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
Octreotide Acetate Injection, 50 mcg (base)/mL recalled
Fresenius Kabi USA is recalling Octreotide Acetate Injection, 50 mcg (base)/mL (0.05 mg/mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 4 May 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-0867-2016
- FDA event ID
- 73811
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2016
- FDA classified
- 24 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 4 May 2016 | Recall initiated by company | |
| 24 May 2016 | Classified by FDA | +20 days |
| 1 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impuities/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
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Impuities/Degradation Specifications
Which lots are affected?
Lot # 6108831; Exp. 07/16
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.
Other products in this recall event
1 other product · FDA event 73811This product is part of a recall event; the main page for the event is Octreotide Acetate Injection, 50 mcg (base)/mL recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Octreotide Acetate Injection, 50 mcg (base)/mL recalled | Fresenius Kabi USA | Potency & Assay | Nationwide |
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 Octreotide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS I | Octreotide Acetate Injection 500 mcg/mL recalled by ViatrisOctreotide Acetate | Viatris | Particulate Matter | Nationwide |