Teva recalls Octreotide Acetate 20mg vials due to potential lack of sterility from manufacturing quality issues. Affected lots expire 9/31/2026 or 3/31/2027.
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 20mg vials for possible lack of sterility. This could lead to infections if the medication is not properly sterile. Patients should not use these vials without contacting their healthcare provider.
The recall is due to quality system deficiencies found during an FDA inspection at the manufacturer. This could mean the medication isn't sterile, potentially causing infections if used.
Patients using Octreotide Acetate for gluteal intramuscular injections. Those with specific lot numbers and expiration dates listed in the recall are most at risk.
Check the vial label for the lot numbers: 4401491, 4401600, 4401603, 4401629 (expiring 9/31/2026) or 4500594, 4500786, 4500920, 4501007, 4501462 (expiring 3/31/2027).
Look for lot numbers 4401491, 4401600, 4401603, 4401629 (expiring 9/31/2026) or 4500594, 4500786, 4500920, 4501007, 4501462 (expiring 3/31/2027) on the vial.
The FDA found quality system deficiencies at the manufacturer during an inspection, which could mean the medication isn't sterile.
Check the vial lot number. If it matches the recalled lots, contact your healthcare provider for guidance.
The recall is for potential lack of sterility, which could cause infections. However, the remedy does not specify stopping use immediately, so the risk is considered low.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0405-2026 — Teva Teva Hello, I own a Teva that is covered by recall D-0405-2026 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.
