Recall Register

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Sagent Pharmaceuticals

FDA recalling firm · 4 enforcement events · 7 product records · 2023–2026 · IL

Sagent Pharmaceuticals has 4 FDA enforcement events on this register (7 product records) between 2023 and 2026: 4 drug; the busiest year was 2024 with 2.

25% of its events are Class I; the most common class is Class II (2). 4 events are listed as ongoing; the recalling firm's address is in IL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
4 May 2026Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.DrugClass III1Ongoing
28 May 2024Docetaxel 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 25021-254-08DrugClass I2Ongoing
25 Apr 2024MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10DrugClass II1Ongoing
11 Jul 2023Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.DrugClass II3Ongoing

By type and class

Drug4
Class II2
Class I1
Class III1

Class I: 25% of this firm's events; 18% of all events on the register.

Events by year

23
24
25
26
Enforcement events for Sagent Pharmaceuticals by year initiated.

Questions and answers

How many FDA recalls has Sagent Pharmaceuticals had?

4 enforcement events (7 product records) on this register, 2023–2026: 4 drug.

Are any Sagent Pharmaceuticals recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are Sagent Pharmaceuticals recalls?

2 Class II, 1 Class I, 1 Class III. 25% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.