The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 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 1,055 (74%) are Severe.

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.

1051–1075 of 1423

  • HighFDA (Drugs)·D-0278-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Nandrolone Decanoate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 701 vials of Nandrolone Decanoate 200 mg/ml because the agency could not ensure the products were sterile.

    Product
    Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2017·2016-12-28

    Meta Pharmacy Recalls Compounded Eye Drops Due to Sterility Concerns

    Meta Pharmacy Services is recalling Phenylephrine and Tropicamide compounded eye drops due to a lack of sterility assurance. The affected product was distributed to one consignee in Las Vegas.

    Product
    Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0184-2017·2016-12-21

    Cantrell Drug Recalls Calcium Chloride Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 80 bags of Calcium Chloride 1 g/50 mL due to a lack of assurance of sterility.

    Product
    Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2017·2016-12-21

    Cantrell Drug Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Neostigmine Methylsulfate injection syringes because the firm cannot ensure the products are sterile.

    Product
    Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0011-2017·2016-10-19

    Leiter's Compounding Recalls Brilliant Blue G Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Brilliant Blue G injections because they were produced using recalled filters, raising concerns about sterility.

    Product
    Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0013-2017·2016-10-19

    Leiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns

    Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a lack of assurance of sterility.

    Product
    Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0010-2017·2016-10-19

    Leiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Leiter's Compounding is recalling Atropine Sulfate 0.01% ophthalmic solution because the filters used to produce the products were recalled, raising concerns about sterility.

    Product
    Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0004-2017·2016-10-12

    The Apothecary Shoppe Recalls Tri-Mix 18/1/10 Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling Tri-Mix 18/1/10 vials because the medication was sterilized using a recalled filter, raising concerns about sterility assurance.

    Product
    Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1543-2016·2016-10-05

    FDA Recalls Pre-Op Pledget Soln + Tetracaine Due to Sterility Concerns

    Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln + Tetracaine vials because the agency cannot ensure the product is sterile.

    Product
    Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1545-2016·2016-10-05

    FDA Recalls Vital Care Compounder Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/ATROP 150/5/5 injection vials due to a lack of assurance of sterility.

    Product
    C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1531-2016·2016-10-05

    Vital Care Compounder Recalls Apomorphine HCl Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Apomorphine HCl 3mg/ml Sterile Injection Solution due to a lack of assurance of sterility.

    Product
    Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1540-2016·2016-10-05

    FDA Recalls Methylcobalamin Vials Due to Lack of Sterility Assurance

    Pharmacy Plus, Inc. is recalling Methylcobalamin 5,000mcg/ml vials due to lack of assurance of sterility. The recall affects 36 vials distributed in Mississippi.

    Product
    Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1534-2016·2016-10-05

    Vital Care Compounder Recalls Papaverine and Phentolamine Vials Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine 150 mg / Phentolamine 5 mg vials due to a lack of assurance of sterility.

    Product
    Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1533-2016·2016-10-05

    FDA Recalls Vital Care Compounder Eye Drops for Sterility Concerns

    The FDA is recalling specific lots of MOXI/DEX/KETOROLAC eye drops from Vital Care Compounder due to a lack of assurance of sterility.

    Product
    MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1463-2016·2016-08-31

    Talon Compounding Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Talon Compounding Pharmacy is recalling Sermorelin and Sermorelin/GHRP-2 injections because the FDA cannot assure the products are sterile.

    Product
    Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1447-2016·2016-08-03

    Medicap Pharmacy Recalls Acetylcyst 10% Ophthalmic Solution for Sterility Concerns

    Medicap Pharmacy is recalling Acetylcyst 10% Ophthalmic Solution because sterile products were not produced in a controlled, sterile environment.

    Product
    Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1302-2016·2016-07-20

    Pharmakon Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 bags of Magnesium Sulfate 1GM in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1343-2016·2016-07-20

    Pharmakon Recalls Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 70 units of Bupivacaine HCI 0.25% bags because the company cannot assure the products are sterile.

    Product
    Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1213-2016·2016-07-20

    Medaus Recalls Manganese Sulfate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Manganese Sulfate vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1315-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 215 bags of Morphine Sulfate in Dextrose due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2016·2016-07-20

    Medaus Recalls B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of B-Complex with Cyanocobalamin vials because the company cannot ensure the product is sterile.

    Product
    B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1225-2016·2016-07-20

    Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C 25/50/50 vials because the product lacks assurance of sterility. The recall affects 2,000 mL in vials distributed in the U.S., Japan, and New Zealand.

    Product
    M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide