Teva Recalls Amikacin Sulfate Injection Due to Glass Particles
Teva Pharmaceuticals recalls specific lots of Amikacin Sulfate injection USP due to the presence of glass particulate matter in vials.
Stop using this now
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling a specific lot of Amikacin Sulfate injection USP because glass particles were found inside one of the vials. This Class I recall affects 6,291 units distributed nationwide and in Puerto Rico. The product was manufactured in Hungary for Teva Pharmaceuticals USA. Read more at govinfonow.com/recall/43126-teva-recalls-amikacin-sulfate-injection-due-to-glass-particles.
Source Summary by GovInfoNow · govinfonow.com/recall/43126-teva-recalls-amikacin-sulfate-injection-due-to-glass-particles · Updated October 11, 2026 · FDA enforcement record: FDA #D-0859-2016
Cite this page
“Teva Recalls Amikacin Sulfate Injection Due to Glass Particles.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43126-teva-recalls-amikacin-sulfate-injection-due-to-glass-particles. Based on FDA recall #D-0859-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0859-2016%22&limit=1).
Why it’s dangerous
The presence of particulate matter identified as glass in the vial poses a serious health risk if injected into a patient. Glass particles can cause embolisms, tissue damage, or other severe complications when introduced directly into the bloodstream.
Who’s affected
Patients who have been prescribed or received Amikacin Sulfate injection USP from the specific lot listed below are at risk. Healthcare providers administering this medication must also be aware of the potential contamination.
How to tell if you have this one
Check for Amikacin Sulfate injection USP, 1 gm/4 mL (250 mg/mL) in a 4mL vial. Look for Individual Pack NDC 0703-9040-01 or Shelf Pack NDC 0703-9040-03. The affected lot number is 4750915 with an expiration date of 9/2017.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Stop Using the Product
Do not use any vials from the recalled lot due to the risk of glass particulate matter.
Contact Healthcare Provider
If you have already received or used this product, contact your healthcare provider immediately for guidance.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0859-2016 (March 9, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0859-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.