Teva Octreotide Acetate Injectable Suspension recalled for sterility concerns
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.
From the FDA notice · Read the official notice ↗ · All Teva recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 1,897 Cartons
- Illnesses reported
- None reported
- Manufactured in
- 400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
- Classification
- Class II
- Recall number
- D-0404-2026
In the FDA's words
- Description
- 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. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027. Distribution: Nationwide in the USA Affected quantity: 1,897 Cartons
- 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.
3 products in this recall
The agency lists each product separately. Check every one you might have.
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen Int… (this page)D-0404-2026 · 1,897 Cartons
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen Int…D-0405-2026 · 19,869 Cartons
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen Int…D-0406-2026 · 21,930 Cartons
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