FDA Drug recall D-0553-2024
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL…
- FDA Drug
- Class I
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class I recall of Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL… by Sagent Pharmaceuticals, citing presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0553-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-28 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sagent Pharmaceuticals |
| Distribution | US |
Product
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Reason
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Identifiers
| ndc | 25021-254-08 |
|---|---|
| ndc | 25021-254-16 |
| code_info | Lot #: F1040001, Exp. Date 12/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0553-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.