Teva Pharmaceuticals USA recalls Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Teva Pharmaceuticals recalls Romidepsin Injecton vials with impurity issues that may affect safety. Learn about affected lots and what to do.
Recall notice
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals is recalling Romidepsin Injecton vials that failed stability testing for impurities. This could pose a risk to patients using the medication. Read more at govinfonow.com/recall/36494-teva-romidepsin-injecton-recall-impurity-risk-in-drug-vials.
Source Summary by GovInfoNow · govinfonow.com/recall/36494-teva-romidepsin-injecton-recall-impurity-risk-in-drug-vials · Updated October 4, 2026 · FDA enforcement record: FDA #D-0309-2021
Cite this page
“Teva Romidepsin Injecton Recall: Impurity Risk in Drug Vials.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36494-teva-romidepsin-injecton-recall-impurity-risk-in-drug-vials. Based on FDA recall #D-0309-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0309-2021%22&limit=1).
Why it’s dangerous
The drug vials showed impurities during stability testing that could affect safety. This means the medication might not be safe for patients when used as intended.
Who’s affected
Patients prescribed Romidepsin Injecton by a doctor are affected. Those using the recalled vials may face potential safety issues.
How to tell if you have this one
Check for vials labeled 'Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only' with NDC 0703-4004-01. Look for specific lot numbers: 31328184C (exp. 11/2021), 31327686C (exp. 08/2021), or 31327685C (exp. 08/2021).
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Details
Identify the vial's lot number and expiration date to confirm if it's recalled.
Questions people ask
Is this product safe to use?
The recall indicates potential impurities that could affect safety, but the official notice does not specify if the product is safe to use.
What should I do if I have this product?
The recall does not provide specific action steps for affected individuals.
How can I check if my vial is recalled?
Check the vial's lot number against the listed numbers: 31328184C (exp. 11/2021), 31327686C (exp. 08/2021), or 31327685C (exp. 08/2021).
Contact Teva Pharmaceuticals
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0309-2021 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0309-2021 from Teva Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0309-2021 (March 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0309-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.