FDA-Drug2026-04-01Class IIPROCESSING DEFECT
Teva Octreotide Acetate Injectable Suspension recalled for sterility concerns
OTHERNationwide distribution
Stop using Teva Octreotide Acetate injection
Teva Pharmaceuticals is recalling specific lots of Octreotide Acetate injectable suspension due to sterility concerns identified at the manufacturing facility. The FDA found quality system deficiencies that could affect the safety of the medication.
- Check if your Octreotide Acetate vials match lot 4401619 (expires 09/30/2026) or lot 4501005 (expires 03/31/2027).
- Do not use recalled vials. Consult your doctor or pharmacist about a replacement immediately.
- Return unused vials to your pharmacy.
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
1,897 Cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 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 0480-9257-08.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0404-2026More 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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