Dr. Red: Docetaxel Injection Recall - Defective Seal Risk
Dr. Reddy's recalls Docetaxel injection vials with defective seals that may open when cap is flipped. This could lead to contamination. Affected units have NDC 43598-611-11 and lot H7044.
Lower-risk recall
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
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What happened, in plain English
Dr. Reddy's is recalling Docetaxel injection vials that have a defective seal which may open when the cap is flipped. This could lead to contamination of the medication. Patients using this product should stop using it and contact their doctor. Read more at govinfonow.com/recall/42092-dr-red-docetaxel-injection-recall-defective-seal-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42092-dr-red-docetaxel-injection-recall-defective-seal-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0213-2018
Cite this page
“Dr. Red: Docetaxel Injection Recall - Defective Seal Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42092-dr-red-docetaxel-injection-recall-defective-seal-risk. Based on FDA recall #D-0213-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0213-2018%22&limit=1).
Why it’s dangerous
The aluminum seal and/or stopper may be removed when the cap is flipped off. This could allow contamination of the medication, potentially leading to ineffective treatment or adverse reactions.
Who’s affected
Patients prescribed Docetaxel injection by a doctor. Those using the recalled vials with NDC 43598-611-11 and lot H7044 are most at risk.
How to tell if you have this one
Check for the NDC code 43598-611-11 and lot number H7044 on the vial label. The product was manufactured in Visakhapatnam, India.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Vial Seal
Inspect the vial for a seal that opens when the cap is flipped off.
Contact Doctor
If the seal is defective, stop using the vial and contact your doctor for alternative treatment.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed nationwide in the USA, Uzbekistan, and Myanmar” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The product may have a defective seal that could open when the cap is flipped, so it is not safe to use without checking.
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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-0213-2018 (January 9, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0213-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.