The Recall Desk

State

Pennsylvania product recalls

20,322 recalls have nationwide distribution and so reach Pennsylvania. 0 additional recalls listed Pennsylvania specifically in their distribution scope.

About recalls in Pennsylvania

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Pennsylvania consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

13301–13325 of 20322

  • 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-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-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-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-0607-2023·2023-05-24

    Cefepime for Injection recalled nationwide for lack of sterility assurance

    Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.

    Product
    Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0595-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Concerns

    Astral SteriTech is recalling Ampicillin and Sulbactam for Injection due to inability to assure product sterility. Approximately 357,550 vials distributed nationwide; no illnesses have been reported.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (Devices)·Z-1609-2023·2023-05-24

    3M Attest Steam Chemical Integrators recalled for potential ink leakage during sterilization

    3M is recalling 3M Attest Steam Chemical Integrators manufactured November 2022–January 2023 due to increased potential for ink leakage during sterilization cycles. Approximately 16.2 million units were distributed worldwide.

    Product
    3M Attest Steam Chemical Integrators, REF 1243A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Potential Calibration Failures

    Beckman Coulter has recalled Bicarbonate reagent used in laboratory testing due to a potential decrease in calibration readings. The issue could result in calibration and quality control failures.

    Product
    Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
    Category
    Medical Device
    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 (Devices)·Z-1582-2023·2023-05-24

    FDA Recalls DuraLife Silicone Breathing Tube Extension Over Sterilization Guidance

    Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.

    Product
    DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
    Category
    Medical Device
    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-0584-2023·2023-05-24

    Ampicillin for Injection Recalled for Lack of Sterility Assurance

    Piramal Critical Care is recalling Ampicillin for Injection nationwide due to lack of sterility assurance. Approximately 8,925 bottles are affected.

    Product
    Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0583-2023·2023-05-24

    Ampicillin for injection recalled nationwide due to sterility concerns

    Ampicillin for Injection (2g per vial) is being recalled nationwide because the manufacturer cannot assure the product meets sterility standards. All 45,160 affected vials in circulation are included.

    Product
    Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Over Sterility Assurance Failure

    The FDA is recalling 11,555 bottles of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The nationwide recall affects all lots within expiry.

    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 66794-208-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0612-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled Due to Sterility Assurance Failure

    Ceftriaxone for Injection is being recalled due to lack of assurance of sterility. The recall affects 65,950 vials distributed nationwide in the United States.

    Product
    Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
    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-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
  • ModerateFDA (Devices)·Z-1588-2023·2023-05-24

    Philips diagnostic imaging systems recalled for missing FDA certification labels

    Philips is recalling 25 CombiDiagnost R90 diagnostic systems nationwide due to missing required FDA certification labels. Affected healthcare facilities should contact Philips for instructions.

    Product
    CombiDiagnost R90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1583-2023·2023-05-24

    Greiner Bio-One Blood Collection Tubes Recalled for Labeling Error

    Greiner Bio-One blood collection tubes (VACUETTE TUBE 6ml K3EDTA) may be incorrectly labeled. The company is recalling 36,000 units distributed in Wisconsin and Georgia.

    Product
    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1608-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Calibration Failure Risk

    Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.

    Product
    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1604-2023·2023-05-24

    Dental implant system recalled for incorrect package length labeling

    Hiossen Inc. is recalling 287 units of ET III Nano-HA dental implants due to incorrect package labeling stating implant length as 10mm when the actual length is 8.5mm. No illnesses or injuries have been reported.

    Product
    ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2023·2023-05-24

    3M Attest Steam Chemical Integrators Recalled for Ink Leakage Risk

    3M is recalling 2.2 million Attest Steam Chemical Integrators (REF 1243B) due to an increased potential for ink leakage during sterilization cycles. No injuries have been reported.

    Product
    3M Attest Steam Chemical Integrators, REF 1243B
    Category
    Medical Device
    Distribution
    Distributed nationwide