Docetaxel Injection — Class I drug recall D-0554-2024
Ongoing recall by Sagent Pharmaceuticals, reported 2024-06-19, distributed nationwide. Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
| Recall number | D-0554-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals, Schaumburg, IL, United States |
| Recall initiated | 2024-05-28 |
| Classified | 2024-06-12 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Quantity | 2,806 vials |
| Reason classes | specification failure |
| NDC | 25021-0254, 25021-0254-08, 25021-0254-16 |
| Lot numbers | F1030001 |
| Expiration dates | 2024-12-31 |
Product
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Reason for recall
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
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-0554-2024. 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.