CLASS II Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation recalled
Dr. Reddy's Laboratories is recalling Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, distributed nationwide in the US. The recall was initiated on 9 Jan 2017 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-0213-2018
- FDA event ID
- 78842
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Docetaxel
- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jan 2017
- FDA classified
- 12 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Jan 2017 | Recall initiated by company | |
| 12 Jan 2018 | Classified by FDA | +368 days |
| 17 Jan 2018 | Published in enforcement report | +5 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: 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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11
Where it was distributed
Distributed nationwide in the USA, Uzbekistan, and Myanmar
Questions about this recall
Is Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation recalled?
Yes. Dr. Reddy's Laboratories recalled Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation on 9 Jan 2017. The recall is Class II and its status is Terminated. Recall number D-0213-2018.
Why was it recalled?
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.
Which lots are affected?
Lot #: H7044, Exp 05/19
Where was it sold?
Distributed nationwide in the USA, Uzbekistan, and Myanmar
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 21 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 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 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Injection USP, 80 mg/, (20 mg/mL), One-Vial Formulation recalledDocetaxel | Dr. Reddy's Laboratories | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | Docetaxel injection concentrate, 20 mg/mL vial recalledDocetaxel | Sanofi-Aventis U.S | Potency & Assay | Nationwide |