The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,055 (74%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all lack of sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

201–225 of 1423

  • HighFDA (Drugs)·D-0614-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 41,500 vials of Ceftriaxone for Injection due to lack of assurance of sterility. The antibiotic was distributed nationwide.

    Product
    Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42
    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-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-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-0642-2023·2023-05-24

    Vancomycin Injectable Solution Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling 413 bags of Vancomycin 2g injectable solution (Lot #AC-016638, expiration 05/27/2023) distributed in Missouri due to lack of assurance of sterility.

    Product
    VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
    Category
    Drug
    Distribution
    1 state
  • 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-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-0600-2023·2023-05-24

    Ampicillin and Sulbactam for Injection recalled nationwide for sterility assurance deficiency

    Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0599-2023·2023-05-24

    Ampicillin and Sulbactam for Injection Recalled for Sterility Assurance Issue

    Astral SteriTech has recalled Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. The recall affects 6,127 bottles.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0610-2023·2023-05-24

    Cefepime Injectable Antibiotic Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling 964,420 vials of Cefepime for Injection due to lack of sterility assurance. The medication was distributed nationwide.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0590-2023·2023-05-24

    Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling 59,040 vials of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0581-2023·2023-05-24

    Ampicillin for Injection Recalled Due to Lack of Sterility Assurance

    Astral SteriTech is recalling 17,350 vials of Ampicillin for Injection nationwide because the manufacturer cannot assure the product's sterility. Healthcare providers and patients should consult their healthcare provider about exposure.

    Product
    Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0608-2023·2023-05-24

    Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 51,280 vials of Cefepime for Injection nationwide because the manufacturer cannot assure that all vials meet sterility requirements. The product is distributed across the United States.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0588-2023·2023-05-24

    Ampicillin for Injection Recalled for Lack of Sterility Assurance

    Ampicillin for Injection is being recalled by Xellia Pharmaceuticals because the manufacturer cannot assure the vials are sterile. The nationwide recall involves 220,340 vials.

    Product
    Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0586-2023·2023-05-24

    Ampicillin for Injection Recalled Due to Sterility Assurance Concerns

    Ampicillin for Injection (500 mg/vial) is being recalled nationwide due to inability to assure sterility. The recall covers approximately 59,530 vials.

    Product
    Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0640-2023·2023-05-24

    Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.

    Product
    VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0604-2023·2023-05-24

    Cefepime for Injection Recalled Due to Lack of Sterility Assurance

    Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.

    Product
    Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0645-2023·2023-05-24

    FDA Recall: VANComycin 750mg Injectable Lacks Sterility Assurance

    Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.

    Product
    VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0603-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Concerns

    Xellia Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. Approximately 23,187 bottles were distributed nationwide; patients should consult their healthcare provider.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0620-2023·2023-05-24

    Ceftriaxone Injection Recalled Over Sterility Assurance Defect

    Astral SteriTech is recalling Ceftriaxone for Injection due to lack of assurance of sterility. The Class II recall affects approximately 7,940 pharmacy bulk packages distributed nationwide.

    Product
    Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0360-2023·2023-03-08

    Phenylephrine injection lacks sterility assurance; FDA recalls vials

    Nephron Sterile Compounding Center has recalled phenylephrine HCl injection vials due to lack of assurance of sterility. Patients and healthcare providers should discontinue use of the affected lots.

    Product
    Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0356-2023·2023-03-08

    Norepinephrine Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 443,483 bottles of Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance in the product.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0362-2023·2023-03-08

    Phenylephrine injection recalled due to lack of sterility assurance

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl injection nationwide due to lack of assurance of sterility. Lot PS2008A with expiration 03/07/2023 is affected.

    Product
    Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
    Category
    Drug
    Distribution
    Distributed nationwide