The Recall Desk

Manufacturer

Sagent Pharmaceuticals Inc

16 recalls in our database name Sagent Pharmaceuticals Inc as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
10
Most recent
2023-05-31

Of the 16 recalls from Sagent Pharmaceuticals Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (63%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • HighFDA (Drugs)·D-0762-2023·2023-05-31

    Nafcillin for Injection recalled nationwide for lack of sterility assurance

    Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP due to lack of assurance of sterility. Approximately 2.2 million vials distributed nationwide are affected.

    Product
    Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0764-2023·2023-05-31

    Nafcillin for Injection Recalled Nationwide for Lack of Sterility Assurance

    Sagent Pharmaceuticals has recalled Nafcillin for Injection due to lack of sterility assurance. The recall affects approximately 370,200 bottles distributed nationwide.

    Product
    Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0763-2023·2023-05-31

    Nafcillin Injectable Medication Recalled for Sterility Assurance Failure

    Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP 2 gram vials nationwide due to lack of assurance of sterility in the manufacturing process. This FDA Class II recall affects multiple lots distributed across the United States.

    Product
    Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0435-2023·2023-03-15

    Heparin Sodium Injection Recalled Due to Labeling Issue

    Sagent Pharmaceuticals is recalling 28,875 vials of Heparin Sodium Injection nationwide due to a labeling issue. Healthcare providers should verify patient medication before administration.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0305-2021·2021-03-24

    Sagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling specific lots of Phenylephrine Hydrochloride Injection due to customer complaints of loose vial overseals that may compromise sterility.

    Product
    PHENYLEPHRINE HYDROCHLORIDE — PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1274-2019·2019-05-15

    Sagent Recalls Ketorolac Tromethamine Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling 75,825 vials of Ketorolac Tromethamine Injection because microbial growth was detected during a routine manufacturing simulation.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0586-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 205,370 vials of methylprednisolone sodium succinate for injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0587-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 176,410 vials of methylprednisolone sodium succinate injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0588-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling methylprednisolone sodium succinate for injection vials due to high impurity levels. The affected lots were distributed nationwide.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1450-2016·2016-08-03

    Sagent Pharmaceuticals Recalls Oxacillin for Injection Due to Particulate Matter

    Sagent Pharmaceuticals is recalling Oxacillin for Injection due to the presence of small, dark particulate matter in the solution after reconstitution.

    Product
    Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0780-2016·2016-03-30

    Sagent Recalls Fluconazole Injection Due to Cross-Contamination with Metronidazole

    Sagent Pharmaceuticals is recalling specific lots of Fluconazole Injection due to cross-contamination with metronidazole. The affected product is distributed nationwide and in Puerto Rico.

    Product
    Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2015·2015-03-11

    Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations suggest potential impacts on product sterility.

    Product
    Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2015·2015-03-11

    Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations regarding aseptic and GMP practices at the manufacturing site may have impacted product sterility.

    Product
    Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1615-2014·2014-10-08

    Sagent Recalls Zoledronic Acid Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling 10,622 bags of Zoledronic Acid Injection because of a lack of assurance of sterility and leaking premix bags.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-605-2013·2013-06-26

    Sagent Recalls Vecuronium Bromide Injection Due to Manufacturing Deviations

    Sagent Pharmaceuticals is recalling Vecuronium Bromide for Injection because it was not manufactured under current good manufacturing practices, resulting in failed impurity specifications.

    Product
    VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Sagent Pharmaceuticals

Country
United States
Founded
2007

Official website

Source: Wikidata (Q28401584), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.