Octreotide Acetate Kit
FDA Recall NDC 0480-9259
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Octreotide Acetate (NDC 0480-9259). A significant event, classified as Class II, was initiated on Apr 24, 2026 by Teva Pharmaceuticals, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Apr 24, 2026
May 13, 2026
2,200 kits
Recall Profile & Regulatory Data
Event ID
98810
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
Batch or Lot Expiration Information
Lot# Lot: 45011002, Exp. 03/31/2027
Affected Packages Involved in this Recall
0480-9257-08Product
0480-9256-01Product
0480-9263-21Product
0480-9259-08Product
0480-9258-01Product
0480-9262-08Product
0480-9260-01Product
Class II Ongoing
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Mar 17, 2026
Apr 01, 2026
1,897 Cartons
Recall Profile & Regulatory Data
Event ID
98609
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, 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.
Batch or Lot Expiration Information
Lot# Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.
Affected Packages Involved in this Recall
0480-9257-08Product
0480-9256-01Product
0480-9263-21Product
0480-9259-08Product
0480-9258-01Product
0480-9262-08Product
0480-9260-01Product
Class II Ongoing
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Mar 17, 2026
Apr 01, 2026
19,869 Cartons
Recall Profile & Regulatory Data
Event ID
98609
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, 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.
Batch or Lot Expiration Information
Lot# Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027.
Affected Packages Involved in this Recall
0480-9257-08Product
0480-9256-01Product
0480-9263-21Product
0480-9259-08Product
0480-9258-01Product
0480-9262-08Product
0480-9260-01Product
Class II Ongoing
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Mar 17, 2026
Apr 01, 2026
21,930 Cartons
Recall Profile & Regulatory Data
Event ID
98609
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, 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.
Batch or Lot Expiration Information
Lot# Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027.
Affected Packages Involved in this Recall
0480-9257-08Product
0480-9256-01Product
0480-9263-21Product
0480-9259-08Product
0480-9258-01Product
0480-9262-08Product
0480-9260-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
