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

Recall Insight

This FDA Drug action (record #D-0553-2024) was formally reported on June 19, 2024, with the manufacturer initiating the action on May 28, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Sagent Pharmaceuticals is listed as the recalling firm, operating out of Schaumburg, IL. Federal records indicate 762 vials units are affected.

The documented reason for this recall is: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Distribution data in the federal record shows the product reached: Nationwide within the USA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.