FDA-Drug2026-04-01Class IIPROCESSING DEFECT
Teva Octreotide Acetate injectable suspension recalled for sterility assurance defect
OTHERNationwide distribution
Stop using recalled Teva Octreotide Acetate injections
Teva Pharmaceuticals is recalling specific lots of Octreotide Acetate 30 mg injectable suspension due to quality control problems found at the manufacturer. The FDA identified deficiencies that mean the sterility of these vials cannot be guaranteed. No injuries have been reported.
- Check if you have one of the affected lot numbers (4400401, 4401393, 4401494, 4401604, 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006)
- Do not use recalled vials; contact your pharmacist or doctor immediately
- Ask your doctor or pharmacist for a replacement or alternative medication
- Return unused vials to your pharmacy for proper disposal
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
21,930 Cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 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 0480-9262-08.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0406-2026More 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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