Teva recalls Octreotide Acetate 10mg vials due to potential sterility issues from manufacturing quality problems. Affected lots manufactured in Greece for gluteal use.
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 10mg vials for injectable use because quality issues at a Greek manufacturer could lead to unsterile products. This poses a risk of infection if the product is used.
The recall is due to quality system failures found during an FDA inspection at the manufacturer. This could mean the product isn't sterile, which might cause infections if injected.
People prescribed Octreotide Acetate for gluteal injections by a doctor. Those with the specific lot numbers listed in the recall are most at risk.
Check the vial label for the lot numbers 4401619 (expiring 09/30/2026) or 4501005 (expiring 03/31/2027). The product is for gluteal intramuscular use only.
Look for lot numbers 4401619 or 4501005 on the vial label.
The product may not be sterile due to manufacturing quality issues, so it should not be used.
Check the lot number on the vial. If it matches 4401619 or 4501005, stop using it and contact your doctor.
The recall was initiated after FDA found quality system deficiencies at the Greek manufacturer.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0404-2026 — Teva Teva Hello, I own a Teva that is covered by recall D-0404-2026 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.
