The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.

1126–1150 of 1691

  • SevereFDA (Drugs)·D-0795-2016·2016-04-06

    Walter's Pharmacy Recalls Edetate Disodium Eye Drops Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Edetate Disodium 2% Ophth Solution because the sterility of the product cannot be assured.

    Product
    Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0798-2016·2016-04-06

    Walter's Pharmacy Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Tobramycin 14 mg/mL Ophthalmic Solution because the product lacks assurance of sterility. The recall affects 10 mL bottles distributed in Pennsylvania.

    Product
    Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1236-2016·2016-03-30

    Ambu Aura Gain Laryngeal Masks Recalled for Sterility Assurance Failure

    Ambu Inc. is recalling Aura Gain laryngeal masks because damage to the sterile barrier may compromise sterility, risking patient contamination.

    Product
    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1137-2016·2016-03-23

    Zimmer Ion Implanted Femoral Stems Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 17 ion implanted femoral stems used in hip arthroplasty due to insufficient sealer calibration data affecting sterility.

    Product
    Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0745-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Morphine Sulfate and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate and Bupivacaine syringes due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0752-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 10 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0764-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 0.5 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0717-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded testosterone cypionate after an FDA inspection identified concerns regarding the assurance of sterility.

    Product
    testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0666-2016·2016-02-24

    Alcon Recalls TEARS Naturale FREE Eye Drops Due to Sterility Concerns

    Alcon is recalling TEARS Naturale FREE eye drops because some vials may contain water instead of the product, creating a sterility risk.

    Product
    TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 9001674110
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0677-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Calcium Compounds for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded calcium products in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0692-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0693-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to lack of sterility assurance found during an FDA inspection.

    Product
    papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0680-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Folic Acid Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Folic Acid, 10 mg/mL, after an FDA inspection identified concerns regarding the assurance of sterility.

    Product
    Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0715-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including progesterone/testosterone, due to lack of sterility assurance found during an FDA inspection.

    Product
    progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0618-2016·2016-02-03

    Sentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues

    Sentara Enterprises is recalling specific lots of Intralipid fat emulsion because the product's sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0632-2016·2016-02-03

    Sentara Recalls Penicillin in D5W Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Penicillin in D5W Homepumps because the sterility of the product cannot be guaranteed.

    Product
    PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0644-2016·2016-02-03

    Sentara Recalls Mycamine Micafungin Sodium Due to Sterility Concerns

    Sentara Enterprises is recalling 10 bags of Mycamine (micafungin sodium) 150mg because product sterility cannot be guaranteed.

    Product
    MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0620-2016·2016-02-03

    Sentara Recalls Dextrose-NaCl Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in Homepumps because product sterility cannot be guaranteed.

    Product
    Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0629-2016·2016-02-03

    Sentara Recalls Cefepime Homepumps Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling specific lots of Cefepime Homepumps because the sterility of the product cannot be guaranteed.

    Product
    CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0639-2016·2016-02-03

    Sentara Recalls Clindamycin Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling 6 bags of Clindamycin 120mg in NS Homepumps because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0640-2016·2016-02-03

    Sentara Recalls Solu-Cortef Syringes Due to Sterility Concerns

    Sentara Enterprises is recalling 9 bags of Solu-Cortef (hydrocortisone) 1MG in NS syringes because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0623-2016·2016-02-03

    Sentara Recalls Vancomycin HCL Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling Vancomycin HCL home infusion bags because the product's sterility cannot be guaranteed. The recall affects bags distributed in Virginia and North Carolina.

    Product
    VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Ho
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0616-2016·2016-02-03

    Sentara Recalls Milrinone Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Milrinone in 0.45% NS homepumps because the sterility of the product cannot be guaranteed.

    Product
    Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0615-2016·2016-02-03

    Sentara Recalls Cefazolin Due to Lack of Sterility Assurance

    Sentara Enterprises is recalling specific lots of Cefazolin because the sterility of the product cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.

    Product
    CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states