Docetaxel Injection USP — Class II drug recall D-1001-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2019-03-20, distributed nationwide. Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
| Recall number | D-1001-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2019-03-06 |
| Classified | 2019-03-12 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2022-05-16 |
| Distributed | Nationwide (US) |
| Quantity | 5,755 vials |
| Reason classes | sterility, packaging |
| NDC | 43598-0258, 43598-0258-11, 43598-0259, 43598-0259-40, 43598-0389, 43598-0389-57 |
| Lot numbers | H7081 |
| Expiration dates | 2019-07 |
Product
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.
Reason for recall
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1001-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.