FDA-Drug2026-04-01Class IIPROCESSING DEFECT
Teva Octreotide Acetate injectable suspension recalled for sterility concerns
OTHERNationwide distribution
Stop using Teva Octreotide Acetate injections
Teva Pharmaceuticals is recalling specific lots of Octreotide Acetate injectable suspension (20 mg) due to quality control issues at the manufacturing facility in Greece. The FDA found deficiencies that could affect sterility—the assurance that the medication is free from harmful bacteria and other microorganisms.
- Check your medication vial for lot numbers: 4401491, 4401600, 4401603, 4401629 (expiring 9/31/2026) or 4500594, 4500786, 4500920, 4501007, 4501462 (expiring 3/31/2027)
- If you have an affected lot, contact your pharmacy or prescriber immediately—do not use the medication
- Ask your doctor or pharmacist for a replacement from a non-recalled lot
Hazard
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Sold states
Nationwide in the USA
Affected count
19,869 Cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0405-2026More Teva Pharmaceuticals USA, Inc recalls
- FDA-Drug2026-04-29Teva Claravis (isotretinoin) 10 mg recalled for elevated tretinoin impurity levels
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.2 mg/day recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.1 mg recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.3 mg recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Isotretinoin 40 mg capsules recalled for inconsistent strength
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