The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 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 1,048 (74%) 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 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.

1376–1400 of 1417

  • SevereFDA (Drugs)·D-451-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-457-2014·2014-01-22

    Calcium Chloride Injection Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Calcium Chloride PF 500 mg/mL prefilled syringes because sterility cannot be assured after a related product was found non-sterile.

    Product
    Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-412-2014·2014-01-22

    FDA Recalls Bevacizumab Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling repackaged Bevacizumab because sterility cannot be assured. The recall affects 2,801 doses distributed in Michigan.

    Product
    Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1027-2013·2013-09-18

    Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance

    South Coast Specialty Compounding is voluntarily recalling Testosterone Cypionate injections due to a lack of sterility assurance.

    Product
    Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1026-2013·2013-09-18

    Park Compounding Recalls Sterile Injection Solutions Due to Sterility Concerns

    Park Compounding is recalling Methylcobalamin, Multitrace-5, and Testosterone Cypionate injections due to lack of sterility assurance.

    Product
    Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-732-2013·2013-07-17

    Gentamicin Injection Recalled for Lack of Sterility Assurance

    Olympia Pharmacy is recalling Gentamicin 0.3% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Gentamicin 0.3% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-632-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Acetylcysteine 10% Solution

    Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 10% Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-661-2013·2013-07-10

    Phenylephrine-cyclopentolate recalled due to lack of assurance of sterility

    Clinical Specialties Compounding Pharmacy is recalling Phenylephrine-cyclopentolate due to FDA inspection findings regarding quality control and sterility.

    Product
    Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-669-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 250 mg-lidocaine 5 mg/ml

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 250 mg-lidocaine 5 mg/ml due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-638-2013·2013-07-10

    Diazepam 5 mg/ml Recalled for Lack of Sterility Assurance

    Clinical Specialties Compounding Pharmacy is recalling Diazepam 5 mg/ml due to FDA inspection findings regarding quality control and lack of sterility assurance.

    Product
    Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-594-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1.5% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-592-2013·2013-06-12

    Pentec Health Recalls Proplete 45-51 KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 45-51 KG intraperitoneal nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-586-2013·2013-06-12

    Pentec Health Recalls Proplete 40 Intradialytic Parenteral Nutrition Bags

    Pentec Health is recalling 9 bags of Proplete 40 intradialytic parenteral nutrition due to a lack of assurance of sterility.

    Product
    Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-587-2013·2013-06-12

    Pentec Health Recalls Proplete 52 Intradialytic Nutrition Due to Sterility Concerns

    Pentec Health is recalling Proplete 52 intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1439-2013·2013-06-12

    Gyrus Acmi Recalls Disposable Myringotomy Knives Due to Sterility Concerns

    Gyrus Acmi is recalling disposable myringotomy knives because they may lack sterility assurance. The affected units were distributed in the US, Canada, and the UK.

    Product
    GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-485-2013·2013-06-05

    Nora Apothecary Recalls Methylcobalamin Injection Syringes Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin 5mg/ml Injection Syringes due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-454-2013·2013-06-05

    Nora Apothecary Recalls Bimix Inj 30:0.5 MDV Penile Injection

    Nora Apothecary and Alternative Therapies, Inc. is recalling Bimix Inj 30:0.5 MDV Penile Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-367-2013·2013-05-22

    Green Valley Drugs Recalls Furosemide Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Furosemide Injection vials because the pharmacy could not ensure the products were sterile. The recall covers 227 vials distributed nationwide.

    Product
    Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-401-2013·2013-05-22

    Green Valley Drugs Recalls Procaine Hydrochloride Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Procaine Hydrochloride Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-412-2013·2013-05-22

    Green Valley Drugs Recalls Sterile Testosterone and Nandrolone Injections

    Green Valley Drugs is recalling specific lots of sterile hormone injections due to a lack of assurance of sterility and quality control concerns.

    Product
    Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-340-2013·2013-05-22

    Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Alpha Lipoic Acid Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-381-2013·2013-05-22

    Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 176 vials of Lipotropic With Vitamins with Methylcobalamin Injections nationwide due to a lack of assurance of sterility.

    Product
    Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-390-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone and Bupivacaine Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone and Bupivacaine Injection due to a lack of assurance of sterility and quality control concerns.

    Product
    Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-348-2013·2013-05-22

    Green Valley Drugs Recalls Betamethasone Sodium Phosphate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Betamethasone Sodium Phosphate Injection because the pharmacy could not ensure the sterility of the compounded products.

    Product
    Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide