CLASS II Drug recall · Reported 20 Mar 2019 · FDA Enforcement Report
Docetaxel Injection USP, 80 mg/, (20 mg/mL), One-Vial Formulation recalled
Dr. Reddy's Laboratories is recalling Docetaxel Injection USP, 80 mg/, (20 mg/mL), One-Vial Formulation, distributed nationwide in the US. The recall was initiated on 6 Mar 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1001-2019
- FDA event ID
- 82323
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Docetaxel
- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2019
- FDA classified
- 12 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Mar 2019 | Recall initiated by company | |
| 12 Mar 2019 | Classified by FDA | +6 days |
| 20 Mar 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Which lots are affected?
Lot#: H7081, Exp 07/2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Docetaxel recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Docetaxel Injection USP 160 mg/ (20 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Docetaxel 60 MG / D5w Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Docetaxel injection concentrate, 20 mg/mL vial recalledDocetaxel | Sanofi-Aventis U.S | Potency & Assay | Nationwide |