Use caution Drug recall · FDA · Published June 18, 2021

Teva Topotecan Injection Recall: Glass Particles Risk Serious Injury

Teva Pharmaceuticals recalls Topotecan Injection vials with glass particles that could cause serious injury during infusion. Affected lots expire April 2022.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0661-2021Drug Teva Pharmaceuticals ›

Use caution until it’s fixed

Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.

Take action

Contact the company

Recalling firmTeva Pharmaceuticals USA400 Interpace Pkwy · Parsippany, NJ 07054-1120

✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals is recalling Topotecan Injection vials that contain glass particles. These particles could cause serious injury if injected into a patient's bloodstream. Read more at govinfonow.com/recall/36114-teva-topotecan-injection-recall-glass-particles-risk-serious-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/36114-teva-topotecan-injection-recall-glass-particles-risk-serious-injury · Updated August 18, 2026 · FDA enforcement record: FDA #D-0661-2021

Cite this page

“Teva Topotecan Injection Recall: Glass Particles Risk Serious Injury.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36114-teva-topotecan-injection-recall-glass-particles-risk-serious-injury. Based on FDA recall #D-0661-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0661-2021%22&limit=1).

The FDA announced on June 18, 2021, that Teva Pharmaceuticals USA voluntarily recalled Topotecan Injection due to the presence of particulate matter. The agency classified the recall as Class I.

How to tell if you have it

Brand: Teva Pharmaceuticals
Product: Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial
Carton NDC# 0703-4714-01
Vial NDC# 0703-4714-71
Lot # 31328962B, exp. date 04/2022

The hazard

The recall addresses complaints of glass particles observed inside the vial. Analysis by Teva identified one grey silicone particle and one translucent, colorless cotton fiber.

Context

GovInfoNow's records show Teva Pharmaceuticals USA has 97 other recalls on record since 2013-10-11. Other recent recalls of similar products include Teva Doxylamine Succinate Tablets Recall (2022-01-18), Teva Tretinoin Capsules 10mg Recall (2022-01-10), and Teva Mimvey Tablets Recall (2022-01-07). Other recent recalls of similar products include Sun Pharmaceutical DOXOrubin Liposome Injection Recall (2026-05-12), American Regent Papaverine HCl Injection Recall (2026-07-24), and Baxter 0.9% Sodium Chloride Injection Recall (2026-08-17).

How to tell if you have this one

Check for vials with NDC# 0703-4714-71. The recall includes lots with expiration date 04/2022, manufactured by Teva Pharmaceuticals USA.

Brand
Teva Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Vial Label
Look for NDC# 0703-4714-71 on the vial label.
Contact Teva
Reach out to Teva Pharmaceuticals for assistance with the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed 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 terminated this recall 10 months after the firm started it.

Jun 18, 2021Firm started the recall
Jul 14, 2021Published in FDA’s Enforcement Report
Jul 15, 2021FDA classified it Class I
Apr 4, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36114-teva-topotecan-injection-recall-glass-particles-risk-serious-injury">Teva Topotecan Injection Recall: Glass Particles Risk Serious Injury (GovInfoNow)</a>

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-0661-2021 (June 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0661-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.