UnratedDrug recall · FDA · Published April 24, 2026
Teva Octreotide Acetate 30mg Kit: Sterility Risk in Injectable Suspension
Teva recalls Octreotide Acetate 30mg single-dose kits due to lack of sterility assurance from FDA inspection. Affected kits have specific NDC codes and lot numbers. No remedy provided in recall notice.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
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Contact the company
📍Recalling firmTeva Pharmaceuticals USA, Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120
✎ GovInfoNow plain-language explainer
Teva Pharmaceuticals is recalling Octreotide Acetate 30mg injectable kits because of quality system issues at the manufacturer that could lead to contamination. This affects patients using the product for gluteal injections. The recall is based on FDA inspection findings, not reported injuries. Read more at govinfonow.com/recall/31334-teva-octreotide-acetate-30mg-kit-sterility-risk-in-injectable-suspension.
“Teva Octreotide Acetate 30mg Kit: Sterility Risk in Injectable Suspension.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31334-teva-octreotide-acetate-30mg-kit-sterility-risk-in-injectable-suspension. Based on FDA recall #D-0519-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2026%22&limit=1).
Teva Pharmaceuticals USA, Inc., with FDA assistance, recalled Octreotide Acetate for Injectable Suspension due to sterility assurance deficiencies, the Food and Drug Administration said on April 24, 2026.
How to tell if you have it
Brand: Teva
Product: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg
NDC Kit Carton: 0480-9262-08
Vial Label: 0480-9260-01
Tray Label: 0480-9262-08
Diluent Label: 0480-9263-21
Lot: 45011002
Expiration Date: 03/31/2027
The hazard
The recall addresses a lack of assurance of sterility resulting from quality system deficiencies identified during a routine FDA inspection at the contract manufacturer, Pharmathen International S.A. in Greece.
Context
GovInfoNow's records show Teva Pharmaceuticals USA, Inc has 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include Cipla Lanreotide Injection Recall: Risk of Contaminated Product (March 13, 2026), Cipla Lanreotide Injection Recall: Risk of Contamination Due to Sterility Issues (March 13, 2026), and Reliance Pemetrexed Injection Recall: Sterility Risk in IV Doses (June 24, 2026).
How to tell if you have this one
Check for NDC kit carton code 0480-9262-08 and lot number 45011002 on the vial label. The product is a single-dose kit for gluteal injections, manufactured in Greece by Pharmathen International S.A.
Brand
Teva
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC kit carton code 0480-9262-08 and lot number 45011002 on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0519-2026 (April 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0519-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.