The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 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 2,114 (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.

2351–2375 of 2384

  • HighFDA (Drugs)·D-407-2013·2013-05-22

    Green Valley Drugs Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 6,213 vials of Sodium Bicarbonate Injection due to a lack of assurance of sterility.

    Product
    Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-316-2013·2013-05-15

    Hospira Recalls Sodium Acetate Injection Due to Sterility Concerns

    Hospira Inc. is recalling 266,900 vials of Sodium Acetate Injection due to loose crimps that may compromise sterility.

    Product
    SODIUM ACETATE — SODIUM ACETATE (SODIUM ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-314-2013·2013-05-15

    Hospira Recalls Furosemide Injection Vials Due to Sterility Concerns

    Hospira Inc. is recalling 259,050 vials of Furosemide Injection due to a loose crimp on the vial cap that compromises sterility assurance.

    Product
    FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-315-2013·2013-05-15

    Hospira Recalls QUELICIN Injection Due to Sterility Concerns

    Hospira Inc. is recalling QUELICIN (succinylcholine chloride) Injection due to a loose crimp on the vial that compromises sterility assurance.

    Product
    QUELICIN — QUELICIN (SUCCINYLCHOLINE CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-308-2013·2013-05-08

    Hospira Recalls Morphine Sulfate Injection Due to Sterility Concerns

    Hospira Inc. is recalling 26,100 vials of Morphine Sulfate Injection because a loose crimp on the vial cap may compromise sterility.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-270-2013·2013-05-01

    Axium Healthcare Recalls TriMix Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling TriMix Injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-276-2013·2013-05-01

    FDA Recalls Methylcobalamin and Folic Acid Injectables Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Methylcobalamin and Folic Acid Injectables because the products may lack sterility assurance.

    Product
    Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-278-2013·2013-05-01

    FDA Recalls Cyclosporin Ophthalmic Vials Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Cyclosporin (Grapeseed Oil) Ophthalmic vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-281-2013·2013-05-01

    Axium Healthcare Recalls Mono-mix Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Mono-mix (Prostaglandin) Injectable due to lack of assurance of sterility and quality control concerns.

    Product
    Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-293-2013·2013-05-01

    Axium Healthcare Recalls Sodium Tetradecyl Sulfate Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate for Injectable due to lack of assurance of sterility and quality control concerns.

    Product
    Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-272-2013·2013-05-01

    Sodium Tetradecyl Sulfate Injectable Recalled for Sterility Assurance Concerns

    Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-275-2013·2013-05-01

    Axium Healthcare Recalls Cyanocobalamin Injectables Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Cyanocobalamin (CMP) Injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-289-2013·2013-05-01

    Axium Healthcare Recalls Bacteriostatic Water for Injection Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling all lots of Bacteriostatic Water for Injection 0.9% due to lack of sterility assurance and quality control concerns.

    Product
    Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-243-2013·2013-04-10

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is recalling 624,240 units of 0.9% Sodium Chloride Injection, USP, 50 mL, due to a lack of assurance of sterility and potential leakage.

    Product
    0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-226-2013·2013-04-03

    CareFusion Recalls Povidone Iodine Applicators Due to Sterility Labeling Errors

    CareFusion is recalling SEPP 10% Povidone Iodine Solution applicators because the product is not sterile, making the sterility claims on the label misleading.

    Product
    SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 2606
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-229-2013·2013-04-03

    CareFusion Recalls FREPP/SEPP Kits Due to Misleading Sterility Labeling

    CareFusion 213, LLC is recalling 544,500 FREPP/SEPP kits because the product is not sterile, but the labeling misleadingly implies it is.

    Product
    FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-219-2013·2013-04-03

    Pfizer Recalls TORISEL Kits Due to Sterility and Endotoxin Concerns

    Pfizer is recalling 10,920 TORISEL (temsirolimus) kits nationwide due to a lack of assurance of sterility and potential low-level endotoxins in the diluent vials.

    Product
    TORISEL — TORISEL (TEMSIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-183-2013·2013-03-13

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is recalling 325,056 bags of 0.9% Sodium Chloride Injection USP, 100 mL, due to a potential lack of assurance of sterility.

    Product
    0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-129-2013·2013-01-23

    James G. Cole Recalls I-C Drops Eye Cleansing Agent for Sterility Labeling

    James G. Cole, Inc. is recalling I-C Drops Eye Cleansing Agent because the label does not state the product is sterile, as required by FDA regulations.

    Product
    I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-121-2013·2013-01-09

    New England Compounding Center Recalls Lidocaine Vials Due to Sterility Concerns

    New England Compounding Center is recalling Lidocaine vials because the FDA determined there is a lack of assurance of sterility.

    Product
    Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-115-2013·2013-01-09

    New England Compounding Center Recalls Clonidine Vials Due to Sterility Concerns

    New England Compounding Center is recalling Clonidine 100 mcg/mL vials nationwide due to a lack of assurance of sterility.

    Product
    Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-112-2013·2013-01-09

    New England Compounding Center Recalls Betamethasone Repository Injections

    New England Compounding Center is recalling Betamethasone Repository injections due to a lack of assurance of sterility. The recall covers all lot codes distributed nationwide.

    Product
    Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide