Octreotide Acetate for Injectable Suspension recall
FDA recall D-0519-2026 · initiated Apr 24, 2026
Teva Pharmaceuticals USA, Inc recalled Octreotide Acetate for Injectable Suspension in Apr 2026 — an FDA Class II recall (D-0519-2026) because Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,200 kits
Details
- Product
- 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.
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 24, 2026
- FDA report date
- May 13, 2026
Frequently asked
- Was Octreotide Acetate for Injectable Suspension recalled?
- Teva Pharmaceuticals USA, Inc recalled Octreotide Acetate for Injectable Suspension in Apr 2026 — an FDA Class II recall (D-0519-2026) because Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Octreotide Acetate for Injectable Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0519-2026 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.
- Is a recalled Octreotide Acetate for Injectable Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Octreotide Acetate for Injectable Suspension are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot: 45011002, Exp. 03/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0519-2026.