Teva Pharmaceuticals recalls Octreotide Acetate vials for gluteal use due to potential sterility issues from manufacturing quality failures. Affected lots expire through 2027.
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 is recalling Octreotide Acetate vials for gluteal injection that may not be sterile due to quality control problems at the manufacturer. This could lead to infections if used improperly.
The vials were made in Greece by a contract manufacturer with quality system issues found during an FDA inspection. This could mean the product isn't sterile, increasing infection risk during injection.
People prescribed Octreotide Acetate for gluteal injections by a doctor who received the recalled vials. Those with the specific lot numbers listed are most at risk.
Check the vial label for the product name 'Octreotide Acetate for Injectable Suspension', gluteal use, 30 mg, 8 mL single-dose vial. Look for lot numbers listed in the recall: 4400401, 4401393, 4401494, etc. The expiration dates range from June 2026 to March 2027.
Look for the product name, gluteal use, 30 mg, 8 mL single-dose vial, and lot numbers listed in the recall.
The FDA found quality system deficiencies at the contract manufacturer during an inspection, which could mean the product isn't sterile.
The recall record does not specify a remedy, so contact your doctor or Teva Pharmaceuticals for guidance.
Yes, the recall lists specific lot numbers: 4400401, 4401393, 4401494, 4401604, 4500564, and others expiring through March 2027.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0406-2026 — Teva Teva Hello, I own a Teva that is covered by recall D-0406-2026 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.
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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.
