The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all 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.

826–850 of 2383

  • SevereFDA (Drugs)·D-0954-2017·2017-07-19

    Advanced Pharma Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 72 units of Potassium Phosphate IV bags nationwide due to a lack of assurance of sterility.

    Product
    Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2017·2017-07-19

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 54,528 bags of 5% Dextrose Injection because the bags may leak, compromising sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0973-2017·2017-07-19

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 295,200 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0939-2017·2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling 5,100 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0941-2017·2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling specific lots of Clindamycin Injection USP due to a lack of assurance of sterility. The recall covers 71,825 vials distributed nationwide.

    Product
    Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0870-2017·2017-06-07

    SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking

    SCA Pharmaceuticals is recalling 80 bags of morphine sulfate injectable solution because the bags are leaking at the seam, compromising sterility.

    Product
    morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0874-2017·2017-06-07

    SCA Pharmaceuticals Recalls Fentanyl Injectable Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling fentanyl citrate injectable bags because they are leaking at the seam, which compromises sterility.

    Product
    fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0879-2017·2017-06-07

    SCA Pharmaceuticals Recalls Phenylephrine Injectable Bags Due to Leaking

    SCA Pharmaceuticals is recalling 30 bags of Phenylephrine HCL injectable solution because the bags are leaking at the seam, compromising sterility.

    Product
    PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0876-2017·2017-06-07

    SCA Pharmaceuticals Recalls Leaking Cefazolin Sodium Injectable Bags

    SCA Pharmaceuticals is recalling 240 bags of cefazolin sodium injectable due to seam leaks that compromise sterility.

    Product
    ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0873-2017·2017-06-07

    SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 370 bags of fentanyl injection solution because the bags were leaking at the seam, compromising sterility.

    Product
    fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0871-2017·2017-06-07

    SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking

    SCA Pharmaceuticals is recalling 56 bags of morphine sulfate in 0.9% Sodium Chloride injectable because the bags are leaking at the seam, compromising sterility.

    Product
    morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0877-2017·2017-06-07

    SCA Pharmaceuticals Recalls Cefazolin Sodium Bags Due to Leaking

    SCA Pharmaceuticals is recalling 70 bags of cefazolin sodium due to leaks at the seam, which compromises the product's sterility.

    Product
    ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0756-2017·2017-05-24

    Key Pharmacy Recalls PGE1/Procaine Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injections because the firm cannot guarantee the products are sterile.

    Product
    PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0717-2017·2017-05-24

    Key Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 10mg/mL injection due to a lack of assurance of sterility.

    Product
    FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0719-2017·2017-05-24

    Key Pharmacy Recalls Folinic Acid Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid MDV Injection due to a lack of assurance of sterility.

    Product
    FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0767-2017·2017-05-24

    Key Pharmacy Recalls GSH/NAC Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling GSH/NAC Inhalation Solution due to a lack of assurance of sterility.

    Product
    GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0768-2017·2017-05-24

    Key Pharmacy Recalls Magnesium Sulfate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% injections because the firm cannot assure the sterility of the product.

    Product
    MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0763-2017·2017-05-24

    Key Pharmacy Recalls Ferric Gluconate Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Ferric Gluconate Injection because the firm cannot guarantee the sterility of the compounded drug.

    Product
    FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0773-2017·2017-05-24

    Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Procaine HCL 1% injections because the firm cannot assure the sterility of the compounded drugs.

    Product
    PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0712-2017·2017-05-24

    Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Atropine Sulfate 0.5% Ophthalmic Solution because the firm cannot assure the sterility of the product.

    Product
    ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0709-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL single-dose vials because the firm cannot assure the sterility of the product.

    Product
    5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0711-2017·2017-05-24

    Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Atropine Sulfate 0.01% Ophthalmic Solution because the firm cannot assure the sterility of the product.

    Product
    ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0769-2017·2017-05-24

    Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 26 vials of Methyl-B12 injection due to a lack of assurance of sterility.

    Product
    METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0754-2017·2017-05-24

    Key Pharmacy Recalls Compounded Quad Mix Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Quad Mix injection due to a lack of assurance of sterility.

    Product
    QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0716-2017·2017-05-24

    FDA Recalls Key Pharmacy Compounded Ferric Gluconate Injection for Sterility Concerns

    Key Pharmacy and Compounding Center is recalling a specific lot of compounded ferric gluconate injection due to a lack of assurance of sterility.

    Product
    FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide