Teva recalls IDArubicin Hydrochloride Injection 5mL vials due to silica and iron oxide particles. This may cause serious complications if injected. Contact Teva for details.
“Teva IDArubicin Injection Recall: Particulate Matter Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35039-teva-idarubicin-injection-recall-particulate-matter-risk. Based on FDA recall #D-0765-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0765-2022%22&limit=1).
The FDA announced on March 29, 2022, that Teva Pharmaceuticals USA Inc. is recalling IDArubicin Hydrochloride Injection USP 5gm/5mL due to the presence of particulate matter. The Class I recall affects 1,565 vials distributed nationwide.
How to tell if you have it
Brand: Teva
Product: IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial
NDC: 0703-4154-11
Lot #: 31329657B
Exp. Date: 08/2023
The hazard
The product was found to contain silica and iron oxide, constituting a hazard of particulate matter presence. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Recent Teva recalls include traZODone 50mg tablets recalled on August 24, 2026, for foreign tablet risk, and Octreotide Acetate 30mg Kit recalled on April 24, 2026, for sterility risk. Other recent recalls of similar products include American Regent Papaverine HCl Injection (July 24, 2026), IMAAVY Injection (September 23, 2026), and American Regent Selenious Acid Injection (July 24, 2026).
How to tell if you have this one
Check for the 5mL single-dose vials labeled 'IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use'. The product was manufactured by Teva Pharmaceuticals USA, Inc. in North Wales, PA with lot number 31329657B and expires 08/2023.
Brand
Teva
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the vial by checking the label for 'IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use' and lot number 31329657B.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0765-2022 (March 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0765-2022 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.