Teva recalls Octreotide Acetate 30mg single-dose kits due to lack of sterility assurance from FDA inspection. Affected kits have specific NDC codes and lot numbers. No remedy provided in recall notice.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals is recalling Octreotide Acetate 30mg injectable kits because of quality system issues at the manufacturer that could lead to contamination. This affects patients using the product for gluteal injections. The recall is based on FDA inspection findings, not reported injuries.
The recall is triggered by FDA finding quality system deficiencies at the manufacturer that could result in non-sterile products. This means the injectable suspension might contain harmful bacteria or other contaminants that could cause infection when injected.
Patients prescribed Octreotide Acetate for gluteal injections who received kits with NDC 0480-9262-08 and lot 45011002 are affected. Those using the product for medical treatment are at risk if the kit is contaminated.
Check for NDC kit carton code 0480-9262-08 and lot number 45011002 on the vial label. The product is a single-dose kit for gluteal injections, manufactured in Greece by Pharmathen International S.A.
Look for NDC kit carton code 0480-9262-08 and lot number 45011002 on the vial label.
The recall notice does not provide a remedy.
The risk is potential contamination from non-sterile products due to quality system issues identified by FDA during an inspection.
Check for NDC kit carton code 0480-9262-08 and lot number 45011002 on the vial label.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0519-2026 — Teva Teva Hello, I own a Teva that is covered by recall D-0519-2026 from Teva. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
