Class II U.S. Food and Drug Administration

Teva Pharmaceuticals USA, Inc Octreotide Acetate for Injectable Suspension recall: Lack of Assurance of Sterility: Quality system deficiencies identified during

Recall published 6 months ago

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0519-2026
Published
May 13, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Teva Pharmaceuticals USA, Inc
Product type
Prescription & OTC drugs
Units affected
2,200 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Lot: 45011002, Exp. 03/31/2027

Products covered by this recall

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.

Check your product

The notice names 12 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 45011002
  • Exp. 03
  • 31
  • 2027 — 2
  • 200 kits

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 03
  • 31
  • 2027 — 2
  • 200 kits

Package size

Match the net weight or the piece count on the front of the pack.

  • 30 mg
  • 8 mL
  • 2 mL

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Teva Pharmaceuticals USA, Inc — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Teva Pharmaceuticals USA, Inc — 400 Interpace Pkwy Bldg A, Parsippany, NJ, 07054-1120

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Teva Pharmaceuticals USA, Inc prescription & otc drugs 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. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 45011002, Exp. 03, 31; best-by date 03 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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