Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Take action
Contact the company
📍Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
✎ GovInfoNow plain-language explainer
Dr. Reddy's Laboratories is recalling one lot of Docetaxel Injection USP because the vial containers have seal and cap defects. These defects could lead to a lack of sterility assurance, meaning the drug might not be sterile when administered. The recall affects 5,755 vials distributed nationwide in the USA. Read more at govinfonow.com/recall/39126-dr-reddy-s-docetaxel-recall-defective-vial-seal-hazard.
“Dr. Reddy's Docetaxel Recall: Defective Vial Seal Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39126-dr-reddy-s-docetaxel-recall-defective-vial-seal-hazard. Based on FDA recall #D-1001-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1001-2019%22&limit=1).
The Food and Drug Administration announced on March 6, 2019, that Dr. Reddy's Laboratories voluntarily recalled Docetaxel Injection USP due to defective container seals and caps that could compromise sterility. The recall affects 5,755 vials distributed nationwide.
The recall addresses complaints regarding seal and cap vial issues that could lead to a lack of sterility assurance. The FDA classified the recall as Class II.
Context
GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has had 85 other recalls on record since April 9, 2012. Other recent recalls by the brand include a Varenicline Tablets recall on November 11, 2025, for subpotent drug risk and a Succinylcholine Chloride Injection recall on September 26, 2025, due to stability testing issues. Other recent recalls of similar products include a Reliance Pemetrexed Injection recall on June 24, 2026, for lack of sterility risk and a Thea Pharma iVIZIA Eye Drops recall on April 23, 2026, for sterility risk from FDA inspection.
How to tell if you have this one
Check if you have Docetaxel Injection USP, 80 mg/4 mL (20 mg/mL), One-Vial Formulation manufactured by Dr. Reddy's Laboratories Limited in India. Specifically look for NDC 43598-259-40 and Lot number H7081 with an expiration date of 07/2019.
Brand
Dr. Reddy's
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop using the product
Do not administer or use any vials matching the recalled lot number H7081 due to sterility risks.
Contact your provider
If you have received this medication, contact your healthcare provider immediately for guidance on next steps and potential replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “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 3.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-1001-2019 (March 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1001-2019 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.