Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurity Issues
Fresenius Kabi USA recalls specific lots of Octreotide Acetate Injection due to failed impurity specifications. Check your vial lot numbers and expiration dates.
Recall notice
Failed Impuities/Degradation Specifications
Contact the company
What happened, in plain English
Fresenius Kabi USA, LLC is recalling specific lots of Octreotide Acetate Injection because the product failed impurity and degradation specifications. The recall affects 355,150 vials distributed nationwide and in Puerto Rico. The record does not specify a remedy or what consumers should do with the affected vials. Read more at govinfonow.com/recall/42849-fresenius-kabi-recalls-octreotide-acetate-injection-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42849-fresenius-kabi-recalls-octreotide-acetate-injection-due-to-impurity-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-0866-2016
Cite this page
“Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42849-fresenius-kabi-recalls-octreotide-acetate-injection-due-to-impurity-issues. Based on FDA recall #D-0866-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2016%22&limit=1).
Why it’s dangerous
The product failed impurity and degradation specifications, meaning the chemical composition may not meet safety standards. The record does not describe the specific health risks or injury mechanisms associated with these failed specifications.
Who’s affected
Patients who have been prescribed Octreotide Acetate Injection by a healthcare provider are likely affected. Individuals possessing the specific lot numbers listed below are at risk of receiving non-compliant medication.
How to tell if you have this one
Check your vial for the brand Fresenius Kabi USA, LLC. Look for NDC 63323-365-01 and one of the following lot numbers: Lot # 6108322 (Exp. 04/16) or Lot # 6108824 (Exp. 07/16). The product is a 50 mcg/mL, 1 mL single-dose vial.
- Brand
Fresenius Kabi- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0866-2016 | 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 63323-365-01.; Lot # 6108322; Exp. 04/16 Lot # 6108824; Exp. 07/16 | 355,150 vials |
| D-0867-2016 | 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; Lot # 6108831; Exp. 07/16 | 40,280 vials |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the recalled vials is 63323-365-01.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0866-2016 (May 4, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0866-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.