Teva Recalls Octreotide Injectable Suspensions Nationwide Over Sterility Concerns

Teva Pharmaceuticals USA, Inc has initiated a voluntary nationwide recall of octreotide acetate for injectable suspension for gluteal intramuscular use in multiple strengths—10 mg, 20 mg, and 30 mg—supplied in single-dose 8 mL vials (NDCs 0480-9257-08, 0480-9259-08, and 0480-9262-08, respectively). The products are manufactured in Greece by Pharmathen International S.A. for Teva Pharmaceuticals, Parsippany, New Jersey. The recall is being conducted at the vial level. A total of 1897 cartons (10 mg), 19 869 cartons (20 mg), and 21 930 cartons (30 mg) are affected.

For the 10 mg strength, the recall applies to lot numbers 4401619 (exp. September 30, 2026) and 4501005 (exp. March 31, 2027). For the 20 mg strength, affected lots include 4401491, 4401600, 4401603, and 4401629 (exp. September 2026), and 4500594, 4500786, 4500920, 4501007, and 4501462 (exp. March 31, 2027). For the 30 mg strength, the recall includes lot 4400401 (exp. June 30, 2026); lots 4401393, 4401494, and 4401604 (exp. September 2026); and lots 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, and 4501006 (exp. March 31, 2027). The firm notified consignees via letter. The recall was initiated on March 17, 2026, and remains ongoing. Distribution occurred nationwide within the United States.

The reason for the recall is lack of assurance of sterility due to quality system deficiencies identified during a routine US Food and Drug Administration (FDA) inspection at the contract manufacturing facility. This issue raises concerns about potential contamination of the injectable product. The recall has been classified by the FDA as Class II (recall numbers D-0404-2026, D-0405-2026, and D-0406-2026; event ID 98609), indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious outcomes. No press release has been issued. The action was voluntary and firm-initiated, and there is no termination date currently listed.

Health care providers and pharmacies should review inventory for the affected lot numbers and follow recall instructions provided in the notification letter. Octreotide is a somatostatin analog indicated for the treatment of acromegaly and for the management of symptoms associated with certain neuroendocrine tumors, including carcinoid tumors and vasoactive intestinal peptide (VIP)-secreting tumors.

Reference

FDA. Enforcement Report. April 1, 2026. Accessed April 2, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm