Teva Pharmaceuticals recalled 1,897 cartons of Octreotide Acetate for Injectable Suspension distributed nationwide in the USA after an FDA inspection flagged sterility concerns. The recall is due to lack of assurance of sterility from the contract manufacturer. Consumers and healthcare providers should stop using the product immediately and contact Teva for guidance.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Octreotide acetate injectable suspension is a prescription medication used to treat certain hormone-secreting tumors and related conditions. It is administered by intramuscular injection, often in a clinical setting.
The hazard is a sterility concern that could lead to contamination and infection if administered. The issue stems from quality control deficiencies identified during an FDA inspection of the contract manufacturer.
This recall is not presented as part of a broader industry pattern in the provided materials.
Patients currently receiving this medication may be affected. The recall covers nearly 1,900 cartons distributed nationwide, requiring clinicians to switch patients to alternative therapies as directed by Teva.
FDA enforcement page for recall D-0404-2026 and Teva recall communications
Refund or replacement policies are not specified in the recall materials. Follow Teva guidance for next steps.
Keep the recall notice and all packaging, labeling, and correspondence. Document lot numbers, expiry dates, and dates of contact with Teva or healthcare providers.
Model numbers/lot numbers: Lot 4401619; Exp. 09/30/2026; 4501005; Exp. 03/31/2027 Where sold: Nationwide in the USA When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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 recalled 21,930 cartons of Octreotide Acetate for Injectable Suspension distributed nationwide in the United States. The recall stems from lack of assurance of sterility identified during an FDA inspection at the contract manufacturer. Healthcare providers and patients should stop using this product immediately and contact Teva or a physician for guidance.
Teva Pharmaceuticals USA recalled 19,869 cartons of Octreotide Acetate for Injectable Suspension nationwide in the United States after FDA inspection flagged lack of assurance of sterility at the contract manufacturer. The FDA cited quality system deficiencies at Pharmathen International S.A. in Greece. Healthcare providers and patients should stop using the product immediately and contact Teva or