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
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 injectable suspension is used to treat conditions like acromegaly and certain tumors. It is administered by a healthcare professional via intramuscular injection.
A sterility defect can lead to contamination and serious infection in patients receiving injections.
This recall is tied to an isolated contract manufacturer issue and does not indicate a widespread industry pattern in the provided data.
Patients and healthcare providers must stop use and seek guidance. The recall is active and affects nearly 20,000 cartons nationwide.
Recall notices and lot information are posted by FDA and Teva; refer to Teva’s site and the FDA enforcement page for details.
Recall is active as of 2026-03-17. Guidance on replacements or refunds will be provided by Teva via recall communications (letters).
Keep recall notices, product packaging, and any correspondence with Teva or healthcare providers. Record any adverse events and report them to the FDA if they occur.
Product: Octreotide Acetate for Injectable Suspension Strength/Volume: 20 mg, 8 mL single-dose vial Form: Injectable suspension Rx: Yes (Rx only) NDC: 0480-9259-08 Manufactured in: Pharmathen International S.A., Rodopi, 693 00 Greece Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054 Quantity: 19,869 cartons Distribution: Nationwide in the USA Lot/Exp: Lot 4401491, 4401600, 4401603, 4401629; Exp. 9/31/2026 Lot: 4500594, 4500786, 4500920, 4501007, 4501462; Exp. 3/31/2027
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 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 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.