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.
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
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Octreotide Acetate for Injectable Suspension is a prescription medication used to treat conditions such as neuroendocrine tumors and acromegaly. It is administered by intramuscular injection in the gluteal region under medical supervision.
The absence of sterility assurance raises risk of infection or contamination in patients receiving injections, potentially leading to serious adverse events.
This recall is not described as part of a broader industry pattern in the provided data.
Medical treatment interruption or infection risk for patients dependent on octreotide therapy, with potential burden on healthcare systems due to recall communication and product replacement.
Recall notices and lot-specific information are available on FDA enforcement pages and Teva communications.
Recall communications by letter; replacement or guidance may take several weeks (typical 4-6 weeks for related recalls).
Keep copy of recall letter, record lot numbers and expiration dates, save packaging, document all communications with Teva and healthcare providers.
Model numbers/lot information: Lot 4400401; Exp. 6/30/2026. Lot 4401393; Lot 4401494; Lot 4401604; Exp. 9/31/2026. Lot 4500564; Lot 4500601; Lot 4500707; Lot 4500796; Lot 4500859; Lot 4500918; Lot 4500919; Lot 4501006; Exp. 3/31/2027. NDC: 0480-9262-08. Sold nationwide in the USA. Manufacturer: Pharmathen International S.A. (Greece). Manufactured for Teva Pharmaceuticals, Parsippany, NJ. Quantity: 21,930 cartons. Product: Octreotide Acetate for Injectable Suspension, 30 mg, 8 mL single-dose vial. Rx only.
No injuries or incidents have been reported.
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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 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
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.