The Recall Desk

Manufacturer

Astral SteriTech Private Ltd.

52 recalls in our database name Astral SteriTech Private Ltd. as the manufacturing or recalling firm.

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.

1–25 of 52

  • HighFDA (Drugs)·D-0622-2023·2023-05-24

    Piperacillin and Tazobactam Injectable Recalled for Sterility Assurance Issue

    Astral SteriTech is recalling 204,860 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The FDA classified this as a Class II recall affecting nationwide distribution.

    Product
    Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2023·2023-05-24

    Ampicillin Injection Vials Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling approximately 89,690 vials of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0629-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance

    The FDA is recalling 169,520 vials of Piperacillin and Tazobactam injectable antibiotic due to lack of assurance of sterility. The affected vials were distributed nationwide.

    Product
    Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0592-2023·2023-05-24

    Ampicillin-Sulbactam Injection Recalled Due to Sterility Concerns

    FDA recalls Ampicillin and Sulbactam for Injection (1.5 grams per vial) manufactured by Astral SteriTech due to lack of sterility assurance. The recall affects 236,610 vials distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0630-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled Due to Sterility Assurance Issue

    Approximately 936,680 vials of Piperacillin and Tazobactam for Injection are being recalled nationwide due to lack of assurance of sterility. All affected lots remain within their expiration dates.

    Product
    Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0625-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure

    Meitheal Pharmaceuticals is recalling Piperacillin and Tazobactam for Injection due to lack of sterility assurance. The recalled product may pose an infection risk to patients if used.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0601-2023·2023-05-24

    Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Defect

    The FDA has recalled Ampicillin and Sulbactam for Injection due to lack of assured sterility. Approximately 119,340 vials distributed nationwide within the United States are affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0580-2023·2023-05-24

    Ampicillin for Injection Recall Due to Sterility Assurance Concerns

    Astral SteriTech is recalling 70,040 vials of Ampicillin for Injection nationwide due to lack of assurance of sterility in the manufacturing process.

    Product
    Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0627-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech recalls 223,590 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assured sterility. Patients and healthcare providers should stop use and consult their provider.

    Product
    Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0619-2023·2023-05-24

    Injectable Ceftriaxone Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.

    Product
    Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0616-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled Nationwide for Sterility Assurance Deficiency

    Astral SteriTech's 66,125-vial ceftriaxone injection is being recalled nationwide due to lack of assurance of sterility in manufacturing. The product is distributed across the United States.

    Product
    Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0624-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled Due to Sterility Assurance Failure

    Astral SteriTech recalls approximately 893,950 vials of piperacillin and tazobactam injection nationwide because the manufacturer cannot assure the product was properly sterilized.

    Product
    Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0611-2023·2023-05-24

    Ceftriaxone injection vials recalled for lack of sterility assurance

    Astral SteriTech is recalling approximately 66,250 vials of Ceftriaxone for Injection due to lack of sterility assurance. The injectable antibiotic poses a potential contamination risk if used.

    Product
    Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0596-2023·2023-05-24

    Ampicillin and Sulbactam for Injection Recalled Due to Sterility Concerns

    Ampicillin and Sulbactam for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 58,770 vials manufactured by Astral SteriTech Private Ltd. are affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0606-2023·2023-05-24

    Cefepime for Injection Recalled Due to Sterility Assurance Concerns

    The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. No illnesses have been reported.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0589-2023·2023-05-24

    Ampicillin Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech has recalled approximately 7,214 bottles of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide within the United States.

    Product
    Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0621-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling approximately 1.3 million vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility during manufacturing.

    Product
    Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2023·2023-05-24

    Ampicillin for Injection Recalled Due to Sterility Assurance Defect

    Astral SteriTech Private Ltd. is recalling Ampicillin for Injection due to manufacturing controls that cannot assure product sterility. The FDA Class II recall affects approximately 80,850 vials distributed nationwide.

    Product
    Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0597-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Failure

    Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0585-2023·2023-05-24

    Ampicillin for Injection Recalled Due to Lack of Sterility Assurance

    Ampicillin for Injection, 250 mg per vial (NDC 70594-084-02) is recalled nationwide due to lack of assurance of sterility. The recall affects 53,220 vials manufactured by Astral SteriTech Private Ltd.

    Product
    Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0623-2023·2023-05-24

    Injectable Antibiotic Recalled Due to Sterility Assurance Defect

    Astral SteriTech is recalling approximately 110,660 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0613-2023·2023-05-24

    Ceftriaxone Injectable Recalled Due to Lack of Sterility Assurance

    Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.

    Product
    Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0617-2023·2023-05-24

    Ceftriaxone for Injection Recalled Due to Sterility Assurance Concerns

    FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.

    Product
    Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0628-2023·2023-05-24

    Antibiotic Injection Vials Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.

    Product
    Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0605-2023·2023-05-24

    Cefepime for Injection Vials Recalled Over Sterility Concerns

    Cefepime for Injection vials are being recalled nationwide due to lack of sterility assurance. The product should not be used and affected individuals should contact their healthcare provider.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
    Category
    Drug
    Distribution
    Distributed nationwide